Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression (DAGMAR)
Primary Purpose
Breast Cancer, Breast Neoplasms, Breast Cancer Female
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soy isoflavones
Lignans
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Lignan capsule
Isoflavones capsule
Placebo capsule
Arm Description
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Apoptosis marker caspase-3
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)
Patient reported outcomes
Well-being
Full Information
NCT ID
NCT04880369
First Posted
May 5, 2021
Last Updated
May 10, 2021
Sponsor
Danish Cancer Society
Collaborators
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04880369
Brief Title
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
Acronym
DAGMAR
Official Title
DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Disapproved by relevant Danish ethical committee
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Cancer Society
Collaborators
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, Breast Cancer Female
Keywords
Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study planned to include 150 women.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lignan capsule
Arm Type
Experimental
Arm Description
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Arm Title
Isoflavones capsule
Arm Type
Experimental
Arm Description
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Arm Title
Placebo capsule
Arm Type
Placebo Comparator
Arm Description
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy isoflavones
Intervention Description
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
Intervention Type
Dietary Supplement
Intervention Name(s)
Lignans
Intervention Description
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
Primary Outcome Measure Information:
Title
Ki-67
Description
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.
Time Frame
Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Secondary Outcome Measure Information:
Title
Apoptosis marker caspase-3
Time Frame
Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Title
Proliferation Index
Description
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)
Time Frame
Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Title
Patient reported outcomes
Description
Well-being
Time Frame
Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)
Other Pre-specified Outcome Measures:
Title
Fecal microbiome:
Description
The microbial community composition will be characterized using the 16sRNA method (Illumina MiSeq Platform).
Time Frame
Change measured in first fecal sample (shortly after diagnosis) to second fecal sample (close to time of surgery). Approx. four months (neo-adjuvant setting)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared upon approval from relevant authorities and in accordance with the law
IPD Sharing Access Criteria
Please request this information from PI Cecilie Kyrø, Ceciliek@cancer.dk
Learn more about this trial
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
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