Breast CancerDAGMARNCT04880369
Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
A study testing Soy isoflavones and Lignans in people with Breast Cancer and Breast Neoplasms, run by Danish Cancer Society.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Soy isoflavones and Lignans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
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
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Being tested
- Soy isoflavones, Lignans, Placebo
- Keywords
- Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavonesDietary supplement
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
LignansDietary supplement
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
PlaceboDietary supplement
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
| Study group | Role | What they receive |
|---|---|---|
| Lignan capsule | Experimental | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) Receives: Dietary Supplement: Lignans |
| Isoflavones capsule | Experimental | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) Receives: Dietary Supplement: Soy isoflavones |
| Placebo capsule | Placebo comparator | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Secondary outcomes (3)
Apoptosis marker caspase-3
Measured: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
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)
Measured: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Patient reported outcomes
Well-being
Measured: Change for completion of first questionnaire (shortly after diagnosis) to second questionnaire (close to time of surgery). Approx. four months (neo-adjuvant setting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study startMar 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Disapproved by relevant Danish ethical committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study planned to include 150 women.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Cecilie Kyrø, Danish Cancer Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880369
- Sponsor's protocol ID
- R174-A11507-17-S52
- Acronym
- DAGMAR
- Status last verified
- Aug 2024
- First submitted
- 5 May 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon approval from relevant authorities and in accordance with the law
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAGMAR: Phytoestrogens and Breast Cancer - Effects of Phytoestrogens on Markers of Disease Progression and Gene Expression
- ClinicalTrials.gov ID
- NCT04880369
- Acronym / sponsor ID
- DAGMAR / R174-A11507-17-S52
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Keywords
- Phytoestrogens, Isoflavones, Lignans, Gene expression, Breast cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Disapproved by relevant Danish ethical committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study planned to include 150 women.
| Arm | Type | Receives |
|---|---|---|
| Lignan capsule | Experimental | Dietary Supplement: Lignans1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
| Isoflavones capsule | Experimental | Dietary Supplement: Soy isoflavones1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Allergic to soy
- Celiac disease
- Inflammatory bowel disease
- Not understanding Danish (patient material and questionnaires are in Danish)
- Prior diagnosis of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy isoflavonesCommercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein). | Dietary supplement | Isoflavones capsule |
| LignansCommercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol) | Dietary supplement | Lignan capsule |
| PlaceboThe placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc. | Dietary supplement | Placebo capsule |
Primary outcome
Ki-67
Time frame: 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.
3 secondary outcomes
Apoptosis marker caspase-3
Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Proliferation Index
Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
Patient reported outcomes
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon approval from relevant authorities and in accordance with the law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Soy isoflavones and Lignans in people with Breast Cancer and Breast Neoplasms, run by Danish Cancer Society.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki-67 (time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.