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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Withdrawn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
Danish Cancer Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    May 5, 2021
    Last Updated
    May 10, 2021
    Sponsor
    Danish Cancer Society
    Collaborators
    Rigshospitalet, Denmark
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    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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