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

NCT04880369 | Withdrawn

• 1 other identifier: R174-A11507-17-S52
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Female

Keywords

Phytoestrogens; Isoflavones; Lignans; Gene expression; Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• 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)

• 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)

Other Outcomes (1)

• 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)

Study Arms (3)

Lignan capsule

EXPERIMENTAL

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Dietary Supplement: Lignans

Isoflavones capsule

EXPERIMENTAL

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Dietary Supplement: Soy isoflavones

Placebo capsule

PLACEBO COMPARATOR

1 capsule/day from baseline to end-of-follow-up (approx. 4 months)

Dietary Supplement: Placebo

Interventions

Soy isoflavones DIETARY_SUPPLEMENT

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

Isoflavones capsule

Lignans DIETARY_SUPPLEMENT

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

Lignan capsule

Placebo DIETARY_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.

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Cancer Society: lead
• Rigshospitalet, Denmark: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Soybean Proteins; Lignans

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study planned to include 150 women.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 10, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Please request this information from PI Cecilie Kyrø, Ceciliek@cancer.dk