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

NCT04880369 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Soy isoflavones

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

DIETARY_SUPPLEMENT

Lignans

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

DIETARY_SUPPLEMENT

Placebo

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 & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Danish Cancer Society

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-07-31
Completion
2022-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880369 on ClinicalTrials.gov