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

Breast Cancer Clinical Trial

— DAGMAR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04880369
• Other study ID #: R174-A11507-17-S52
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Disease Progression

Intervention

Dietary Supplement:
• Soy isoflavones
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
• Lignans
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Danish Cancer Society	Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal microbiome:	The microbial community composition will be characterized using the 16sRNA method (Illumina MiSeq Platform).	Change measured in first fecal sample (shortly after diagnosis) to second fecal sample (close to time of surgery). Approx. four months (neo-adjuvant setting)
Primary	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	Apoptosis marker caspase-3		Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Secondary	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)	Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Secondary	Patient reported outcomes	Well-being	Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)