Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00096356
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2004-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
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'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'glesser@wakehealth.edu', 'phone': '(336) 713-5440', 'title': 'Dr. Glenn Lesser', 'organization': 'Wake Forest University Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 weeks', 'description': 'One month past the end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 - CoQ10 & Vitamin E', 'description': 'CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.', 'otherNumAtRisk': 100, 'otherNumAffected': 89, 'seriousNumAtRisk': 100, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo-Vitamin E 100 mg/day in 3 doses', 'otherNumAtRisk': 93, 'otherNumAffected': 84, 'seriousNumAtRisk': 93, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 16, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 83, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 80, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 48, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 53, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 44, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 75, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 71, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'WBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'L vent sy d', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'abd pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - CoQ10 & Vitamin E', 'description': 'CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.'}, {'id': 'OG001', 'title': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo-Vitamin E 100 mg/day in 3 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '6.96', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1815', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.37', 'ciLowerLimit': '-3.39', 'ciUpperLimit': '0.64', 'pValueComment': 'The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'estimateComment': 'This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.', 'groupDescription': 'Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - CoQ10 & Vitamin E', 'description': 'CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.'}, {'id': 'OG001', 'title': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo-Vitamin E 100 mg/day in 3 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '111.8', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.99', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '6.53', 'pValueComment': '0.05 significance level; no multiple comparison adjustment', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.31', 'estimateComment': 'This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.', 'groupDescription': 'Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1- CoQ10 & Vitamin E', 'description': 'CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.'}, {'id': 'OG001', 'title': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo-Vitamin E 100 mg/day in 3 doses'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.6014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '1.88', 'pValueComment': '0.05 significance level, unadjusted for multiple comparisons', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.31', 'estimateComment': 'This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.', 'groupDescription': 'Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 - CoQ10 + Vitamin E', 'description': 'CoQ10 + Vitamin E 100mg/day in 3 doses'}, {'id': 'FG001', 'title': 'Arm 2 - Placebo + Vitamin E', 'description': 'Placebo + Vitamin E 100mg/day in 3 doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Recruitment occurred in medical clinics', 'preAssignmentDetails': 'There was no run-in period. Everyone enrolled was randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 - CoQ10 & Vitamin E', 'description': 'CoQ10 plus Vitamin E 100mg/day in 3 doses'}, {'id': 'BG001', 'title': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo plus Vitamin E 100mg/day in 3 doses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2009-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2004-11-09', 'resultsFirstSubmitDate': '2014-09-08', 'studyFirstSubmitQcDate': '2004-11-08', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-17', 'studyFirstPostDateStruct': {'date': '2004-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization', 'timeFrame': '24 weeks', 'description': 'POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.'}], 'secondaryOutcomes': [{'measure': 'Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization', 'timeFrame': '24 weeks', 'description': 'FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.'}, {'measure': 'Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization', 'timeFrame': '24 weeks', 'description': 'CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '29731611', 'type': 'BACKGROUND', 'citation': 'Vitolins MZ, Case LD, Rapp SR, Lively MO, Shaw EG, Naughton MJ, Giguere J, Lesser GJ. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol. Patient Prefer Adherence. 2018 Apr 24;12:637-646. doi: 10.2147/PPA.S158682. eCollection 2018.'}, {'pmid': '22682875', 'type': 'RESULT', 'citation': 'Lesser GJ, Case D, Stark N, Williford S, Giguere J, Garino LA, Naughton MJ, Vitolins MZ, Lively MO, Shaw EG; Wake Forest University Community Clinical Oncology Program Research Base. A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.\n\nPURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the effect of coenzyme Q\\_10 on cancer treatment-related fatigue in women with breast cancer.\n\nSecondary\n\n* Determine the effect of this drug on overall quality of life of these patients.\n* Determine the effect of this drug on depression in these patients.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q\\_10 and oral vitamin E three times daily.\n* Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.\n\nTreatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.\n\nQuality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.\n\nPROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent\n* Hg \\> 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels\n* Total cholesterol \\> 160mg/dL.\n* Female with primary cancer diagnosis (breast)\n* Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)\n* KPS \\> 60\n* Bilirubin \\< 1.5 x ULN\n* SGOT \\< 2.5 x ULN\n* SGPT \\< 2.5 x ULN\n\nExclusion Criteria:\n\n* Recent involuntary weight loss (\\> 5% of body weight in the past 3 months)\n* Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)\n\n * Atorvastatin (Lipitor)\n * Cerivastatin\n * Fluvastatin (Lescol)\n * Lovastatin (Mevacor, Altocor, Advicor)\n * Mevastatin\n * Pravastatin (Pravachol)\n * Rosuvastatin\n * Simvastatin (Zocor)\n* Current or planned use of the following medications for fatigue\n\n * Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)\n * Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)\n* Patients diagnosed with uncontrolled hypertension\n* Breast cancer patients who are male\n* Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.\n* Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)\n* Patients with uncontrolled thyroid dysfunction'}, 'identificationModule': {'nctId': 'NCT00096356', 'acronym': 'CoQ10', 'briefTitle': 'Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'REBACCCWFU-97202'}, 'secondaryIdInfos': [{'id': 'U10CA081851', 'link': 'https://reporter.nih.gov/quickSearch/U10CA081851', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 - CoQ10 & Vitamin E', 'description': 'CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.', 'interventionNames': ['Dietary Supplement: CoQ10 & Vitamin E', 'Dietary Supplement: Placebo & Vitamin E']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2 - Placebo & Vitamin E', 'description': 'Placebo-Vitamin E 100 mg/day in 3 doses', 'interventionNames': ['Dietary Supplement: Placebo & Vitamin E']}], 'interventions': [{'name': 'CoQ10 & Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CoenzymeQ10'], 'armGroupLabels': ['Arm 1 - CoQ10 & Vitamin E']}, {'name': 'Placebo & Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Arm 1 - CoQ10 & Vitamin E', 'Arm 2 - Placebo & Vitamin E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'CCOP - Santa Rosa Memorial Hospital', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F. Graham Cancer Center at Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MBCCOP - Howard University Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'MBCCOP - JHS Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Michigan Cancer Research Consortium', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073-6769', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Beaumont', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Cancer Research for the Ozarks', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Heartland Research Consortium', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - St. Louis-Cape Girardeau', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27216', 'city': 'Burlington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Alamance Cancer Center at Alamance Regional Medical Center', 'geoPoint': {'lat': 36.09569, 'lon': -79.4378}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Medical Oncology Center - Goldsboro', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '28791', 'city': 'Hendersonville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pardee Memorial Hospital', 'geoPoint': {'lat': 35.31873, 'lon': -82.46095}}, {'zip': '27261', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'High Point Regional Hospital', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '28645', 'city': 'Lenoir', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Caldwell Memorial Hospital', 'geoPoint': {'lat': 35.91402, 'lon': -81.53898}}, {'zip': '27104-4241', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157-1030', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Comprehensive Cancer Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas - Eastside', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29925', 'city': 'Hilton Head Island', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Cancer Specialists, PA at Hilton Head Medical Center', 'geoPoint': {'lat': 32.19382, 'lon': -80.73816}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Danville Regional Medical Center', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': '24115-4788', 'city': 'Martinsville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County', 'geoPoint': {'lat': 36.69153, 'lon': -79.87254}}], 'overallOfficials': [{'name': 'Glenn J. Lesser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}