Breast Cancer, Breast Neoplasms, Breast Cancer Female
Conditions
Keywords
Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTSoy isoflavones
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
DIETARY_SUPPLEMENTLignans
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
DIETARY_SUPPLEMENTPlacebo
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
Sponsors
Rigshospitalet, Denmark
Danish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The study planned to include 150 women.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ki-67 | Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apoptosis marker caspase-3 | Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting) | — |
| Proliferation Index | Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting) | 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) |
| Patient reported outcomes | Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting) | Well-being |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiome: | Change measured in first fecal sample (shortly after diagnosis) to second fecal sample (close to time of surgery). Approx. four months (neo-adjuvant setting) | The microbial community composition will be characterized using the 16sRNA method (Illumina MiSeq Platform). |
Outcome results
None listed