Clinical trial · Interventional
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Disapproved by relevant Danish ethical committee
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lignans | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Soy isoflavones | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with breast cancer at "Brystkirurgisk Afdeling" at Rigshospitalet and Herlev Hospitals (within the last 30 days). * 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: * Allergic to soy * 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
References
Publications (0)
Data not yet available