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

Sponsor

Danish Cancer Society (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04880369

Collaborator

Rigshospitalet, Denmark (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Neoplasms Breast Cancer Female	Dietary Supplement: Soy isoflavones Dietary Supplement: Lignans Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study planned to include 150 women.The study planned to include 150 women.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lignan capsule 1 capsule/day from baseline to end-of-follow-up (approx. 4 months)	Dietary Supplement: Lignans Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
Experimental: Isoflavones capsule 1 capsule/day from baseline to end-of-follow-up (approx. 4 months)	Dietary Supplement: Soy isoflavones Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
Placebo Comparator: Placebo capsule 1 capsule/day from baseline to end-of-follow-up (approx. 4 months)	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.

Arm

Intervention/Treatment

Experimental: Lignan capsule

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

Dietary Supplement: Lignans

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

Experimental: Isoflavones capsule

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

Dietary Supplement: Soy isoflavones

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

Placebo Comparator: Placebo capsule

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

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.

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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