Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression

Danish Cancer Society

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Breast Cancer Breast Neoplasms Breast Cancer Female

Interventions

Soy isoflavonesDIETARY_SUPPLEMENT

Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).

LignansDIETARY_SUPPLEMENT

Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)

PlaceboDIETARY_SUPPLEMENT

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

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ki-67

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.

Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)

Secondary Outcomes

Apoptosis marker caspase-3

Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)

Proliferation Index

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)

Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)

Patient reported outcomes

Well-being

Time frame: Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)

Data from ClinicalTrials.gov

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