Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT04880369
Status:
WITHDRAWN
Last Update Posted:
2024-08-07
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D030262', 'term': 'Soybean Proteins'}, {'id': 'D017705', 'term': 'Lignans'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D001593', 'term': 'Benzyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study planned to include 150 women.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Disapproved by relevant Danish ethical committee', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-05', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal microbiome:', 'timeFrame': 'Change measured in first fecal sample (shortly after diagnosis) to second fecal sample (close to time of surgery). Approx. four months (neo-adjuvant setting)', 'description': 'The microbial community composition will be characterized using the 16sRNA method (Illumina MiSeq Platform).'}], 'primaryOutcomes': [{'measure': 'Ki-67', 'timeFrame': 'Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)', 'description': 'Ki-67 can be measured using immunohistochemistry (IHC) and using the transcript from gene expression data (see secondary outcomes). As the latter is superior and less biased, the Ki-67 based on the transcript will be used as primary measure of Ki67.'}], 'secondaryOutcomes': [{'measure': 'Apoptosis marker caspase-3', 'timeFrame': 'Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)'}, {'measure': 'Proliferation Index', 'timeFrame': 'Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)', 'description': 'Based on expression data from 79 genes encoding proliferative and cell cycle markers. Gene expression will be analyzed using a microarray (GeneChip® Human Genome U133 Plus 2.0 Array, Affymetrix, USA)'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)', 'description': 'Well-being'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phytoestrogens', 'Isoflavones', 'Lignans', 'Gene expression', 'Breast cancer'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate if soy isoflavones and lignans affect markers of disease progression and gene expression among breast cancer patients receiving neo-adjuvant treatment in a three arm, double-blinded, randomized placebo-controlled trial (RCT) comparing: soy isoflavone supplementation, lignan supplementation, and placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days).\n* Advised (and accepted) to receive neo-adjuvant treatment\n* Primary unilateral breast cancer\n* Treatment is expected to be curative\n* Is expected to be able to attend surgery\n\nExclusion Criteria:\n\n* Allergic to soy\n* Celiac disease\n* Inflammatory bowel disease\n* Not understanding Danish (patient material and questionnaires are in Danish)\n* Prior diagnosis of breast cancer\n* Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis'}, 'identificationModule': {'nctId': 'NCT04880369', 'acronym': 'DAGMAR', 'briefTitle': 'Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression', 'organization': {'class': 'OTHER', 'fullName': 'Danish Cancer Society'}, 'officialTitle': 'DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression', 'orgStudyIdInfo': {'id': 'R174-A11507-17-S52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lignan capsule', 'description': '1 capsule/day from baseline to end-of-follow-up (approx. 4 months)', 'interventionNames': ['Dietary Supplement: Lignans']}, {'type': 'EXPERIMENTAL', 'label': 'Isoflavones capsule', 'description': '1 capsule/day from baseline to end-of-follow-up (approx. 4 months)', 'interventionNames': ['Dietary Supplement: Soy isoflavones']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'description': '1 capsule/day from baseline to end-of-follow-up (approx. 4 months)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Soy isoflavones', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).', 'armGroupLabels': ['Isoflavones capsule']}, {'name': 'Lignans', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)', 'armGroupLabels': ['Lignan capsule']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.', 'armGroupLabels': ['Placebo capsule']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data will be shared upon approval from relevant authorities and in accordance with the law', 'accessCriteria': 'Please request this information from PI Cecilie Kyrø, Ceciliek@cancer.dk'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Cancer Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cecilie Kyrø', 'investigatorAffiliation': 'Danish Cancer Society'}}}}