Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
NCT ID: NCT04880369
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-03-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Lignan capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Lignans
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
Isoflavones capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Soy isoflavones
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
Placebo capsule
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Placebo
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
Interventions
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Soy isoflavones
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
Lignans
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
Placebo
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
Eligibility Criteria
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Inclusion Criteria
* Advised (and accepted) to receive neo-adjuvant treatment
* Primary unilateral breast cancer
* Treatment is expected to be curative
* Is expected to be able to attend surgery
Exclusion Criteria
* Celiac disease
* Inflammatory bowel disease
* Not understanding Danish (patient material and questionnaires are in Danish)
* Prior diagnosis of breast cancer
* Use of dietary supplements containing lignans or isoflavones three months prior to diagnosis
18 Years
99 Years
FEMALE
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Danish Cancer Society
OTHER
Responsible Party
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Cecilie Kyrø
Principal Investigator
Other Identifiers
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R174-A11507-17-S52
Identifier Type: -
Identifier Source: org_study_id
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