Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT01849250
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2013-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D010144', 'term': "Paget's Disease, Mammary"}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PHBrown@mdanderson.org', 'phone': '713-792-7734', 'title': 'Powel H. Brown, MD/Chair, Clinical Cancer Prevention', 'organization': 'The University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected over 12 weeks of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.', 'otherNumAtRisk': 32, 'otherNumAffected': 17, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.', 'otherNumAtRisk': 32, 'otherNumAffected': 15, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspepsia - Heart Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal disorders - Other: Burping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal disorders - Other: Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastrointestinal disorders - Other: Loose stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Heart failure, Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, Chest Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Skin and subcutaneous tissue disorders - other, Poison Ivy Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment vs. Baseline Change', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.50', 'groupIds': ['OG000'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Differences in normal breast tissue levels of TNF-α 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-α levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (ΔΔCT) analysis protocol.', 'unitOfMeasure': 'Log Transformed Relative ExpressionLevel', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants in the Placebo group and 1 participant in the DHA group were not evaluable due to tissue was not available quantitative RT-PCR.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Crown-like Structures of the Breast (CLS-B) at Baseline and Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Positive both Baseline and Post-treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to 12 weeks', 'description': 'An indicator of whether a subject is detected with CLS-B or not.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants on the placebo arm and 1 participant on the DHA arm did not have a post treatment biopsy.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in CLS-B/cm^2 Adjusted for the Pre-treatment Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'timeFrame': 'Baseline to 12 weeks', 'description': 'To assess the severity of CLS-B using the following formula: number of CLS-B/cm\\^2. The absolute change in the CLS-B/cm\\^2 calculated according to the formula; Change in CLS-B/cm\\^2 = (post-treatment CLS-B/cm\\^2) - (pre-treatment CLS-B/cm\\^2).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Breast Tissue Cox 2 mRNA Levels at Baseline and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline COX-2', 'categories': [{'measurements': [{'value': '0.49', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment COX-2', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.19', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Biomarkers COX-2 are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.', 'unitOfMeasure': 'relative expression level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with adequate RNA available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in the Breast Tissue IL- Beta mRNA Levels of Tissue Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline IL-Beta', 'categories': [{'measurements': [{'value': '0.62', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment IL-Beta', 'categories': [{'measurements': [{'value': '0.23', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Biomarkers IL-1Beta are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.', 'unitOfMeasure': 'relative expression level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with adequate RNA available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Difference in the Breast Tissue Aromatase mRNA Levels of Tissue Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid', 'description': 'Docosahexaenoic Acid (DHA) 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline Aromatase', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '2.38', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment Aromatase', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Biomarkers Aromatase are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.', 'unitOfMeasure': 'relative expression level', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with adequate RNA available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Red Blood Cell (RBC) Fatty Acid Level as a Surrogate of Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'OG001', 'title': 'Docosahexaenoic Acid (DHA)', 'description': 'Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.'}], 'classes': [{'title': 'Baseline Omega3 index', 'categories': [{'measurements': [{'value': '5.03', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'Baseline DHA level', 'categories': [{'measurements': [{'value': '4.53', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment Omega3 index', 'categories': [{'measurements': [{'value': '4.92', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '11.95', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment DHA level', 'categories': [{'measurements': [{'value': '4.41', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment v. Baseline Change Omega3 index', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '.068', 'groupId': 'OG000'}, {'value': '6.99', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Post Treatment v. Baseline Change DHA level', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '6.78', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'Whole blood samples collected for red blood cell fatty acid analyses at baseline and week 12 (+ 2 weeks). RBC fatty acid composition analyzed by gas chromatography (GC) with flame ionization detection.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available blood samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'FG001', 'title': 'Docosahexaenoic Acid (DHA)', 'description': 'Docosahexaenoic Acid 1000 mg orally twice a day for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not Evaluable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment Period: May 1 ,2013 to December 31, 2015. All recruitment done in medical settings.', 'preAssignmentDetails': 'Of 65 participants enrolled, one was not eligible thus excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo orally twice a day for 12 weeks.'}, {'id': 'BG001', 'title': 'Docosahexaenoic Acid', 'description': 'DHA 1000 mg orally twice a day for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '62'}, {'value': '59.5', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '63'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '62'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-03', 'studyFirstSubmitDate': '2013-05-06', 'resultsFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2013-05-06', 'lastUpdatePostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-03', 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Differences in normal breast tissue levels of TNF-α 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-α levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (ΔΔCT) analysis protocol.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Crown-like Structures of the Breast (CLS-B) at Baseline and Post-treatment', 'timeFrame': 'Baseline to 12 weeks', 'description': 'An indicator of whether a subject is detected with CLS-B or not.'}, {'measure': 'Absolute Change in CLS-B/cm^2 Adjusted for the Pre-treatment Measurements', 'timeFrame': 'Baseline to 12 weeks', 'description': 'To assess the severity of CLS-B using the following formula: number of CLS-B/cm\\^2. The absolute change in the CLS-B/cm\\^2 calculated according to the formula; Change in CLS-B/cm\\^2 = (post-treatment CLS-B/cm\\^2) - (pre-treatment CLS-B/cm\\^2).'}, {'measure': 'Breast Tissue Cox 2 mRNA Levels at Baseline and 12 Weeks', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Biomarkers COX-2 are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.'}, {'measure': 'Mean Difference in the Breast Tissue IL- Beta mRNA Levels of Tissue Biomarkers', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Biomarkers IL-1Beta are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.'}, {'measure': 'Mean Difference in the Breast Tissue Aromatase mRNA Levels of Tissue Biomarkers', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Biomarkers Aromatase are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis.'}, {'measure': 'Red Blood Cell (RBC) Fatty Acid Level as a Surrogate of Compliance', 'timeFrame': 'Baseline and week 12', 'description': 'Whole blood samples collected for red blood cell fatty acid analyses at baseline and week 12 (+ 2 weeks). RBC fatty acid composition analyzed by gas chromatography (GC) with flame ionization detection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Benign Breast Neoplasm', 'Ductal Breast Carcinoma In Situ', 'Invasive Breast Carcinoma', 'Lobular Breast Carcinoma In Situ', 'Paget Disease of the Breast', 'Stage IA Breast Cancer', 'Stage IB Breast Cancer', 'Stage IIA Breast Cancer', 'Stage IIB Breast Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.\n\nSECONDARY OBJECTIVES:\n\nI. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers\n\n* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).\n* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.\n* Change from baseline in CLS-B index determined as follows: (\\[number of slides with evidence of at least one CLS-B\\]/\\[total number of slides examined\\]).\n* Change from baseline in CLS-B/cm\\^2 defined as the number of CLS-B/cm\\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.\n\nIII. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.\n\nARM II: Patients receive placebo PO BID for 12 weeks."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease\n* No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator\n* \\>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)\n* Participants must have a body mass index (BMI) \\>= 25, defined as (weight in kilograms/\\[height in meters\\]\\^2)\n* Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted\n* Daily DHA consumption =\\< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire\n* Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System \\[BI-RADS\\] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo)\n* Eastern Cooperative Oncology Group (ECOG) performance status must be =\\< 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,500/uL\n* Platelets \\>= 75,000/uL\n* White blood cells \\>= 3,000/uL\n* Hemoglobin \\>= 10 g/dL\n* Total bilirubin within 1.5 times the institution's upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) within 1.5 times the institution's ULN\n* Serum creatinine within 1.5 times the institution's ULN\n* Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy\n* Willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months\n* A history of histologically-confirmed bilateral invasive breast cancer\n* Bilateral mastectomy\n* Prior history or evidence of metastatic breast cancer\n* Prior radiation therapy to the contralateral (unaffected) breast\n* Prior history of contralateral (unaffected) breast augmentation with breast implant placement\n* History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry\n* History of DHA supplementation \\> 200 mg/day in the month preceding study entry\n* History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators\n* History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year\n* Participants may not be receiving any other investigational agents during the study\n* Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation\n* Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening\n* Individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHA or corn/soy oil in placebo agent\n* Pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method"}, 'identificationModule': {'nctId': 'NCT01849250', 'briefTitle': 'Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease', 'orgStudyIdInfo': {'id': 'NCI-2013-00859'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00859', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '12-474'}, {'id': '12-267'}, {'id': 'N01-CN-2012-00034'}, {'id': 'DFCI:12- 474', 'type': 'OTHER', 'domain': 'Dana-Farber Cancer Institute (DFCI)'}, {'id': 'AAAK6752'}, {'id': 'MSKCC-12-267', 'type': 'OTHER', 'domain': 'Memorial Sloan Kettering Cancer Center (MSK or MSKCC)'}, {'id': 'H-33017'}, {'id': 'CUMC: AAAK6752'}, {'id': '2011-0766', 'type': 'OTHER', 'domain': 'MD Anderson Cancer Center (MDA or MDACC)'}, {'id': 'MDA10-16-01', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'N01CN00034', 'link': 'https://reporter.nih.gov/quickSearch/N01CN00034', 'type': 'NIH'}, {'id': 'N01CN35159', 'link': 'https://reporter.nih.gov/quickSearch/N01CN35159', 'type': 'NIH'}, {'id': 'P30CA016672', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016672', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Docosahexaenoic Acid)', 'description': 'Docosahexaenoic Acid orally twice a day (PO BID) for 12 weeks.', 'interventionNames': ['Drug: Docosahexaenoic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (placebo)', 'description': 'Placebo orally twice a day (PO BID) for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Docosahexaenoic Acid', 'type': 'DRUG', 'otherNames': ['Fatty Acid 22:6'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (Docosahexaenoic Acid)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University/Herbert Irving Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ayca Gucalp', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}, {'name': 'Powel H. Brown, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}