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

Not Applicable

Withdrawn

• Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Female
• Interventions: Dietary Supplement: Lignans; Dietary Supplement: Soy isoflavones; Dietary Supplement: Placebo

• Registration Number: NCT04880369
• Lead Sponsor: Danish Cancer Society

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Primary Completion: 2022-07
• Study Completion: 2022-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lignan capsule	Lignans	1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Isoflavones capsule	Soy isoflavones	1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Placebo capsule	Placebo	1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
Apoptosis marker caspase-3	Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)