An interventional study of Soy isoflavones and Lignans in Breast Cancer, Breast Neoplasms and Breast Cancer Female, sponsored by Danish Cancer Society. Withdrawn. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Prevention
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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.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Dietary Supplement: Lignans
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Dietary Supplement: Soy isoflavones
1 capsule/day from baseline to end-of-follow-up (approx. 4 months)
Dietary Supplement: Placebo
Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
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.
Time frame: Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting)
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
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)
Patient reported outcomes
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)
Fecal microbiome:
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)
No study locations are listed for this record.
Plan to share: Yes — Data will be shared upon approval from relevant authorities and in accordance with the law
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Access criteria: Please request this information from PI Cecilie Kyrø, Ceciliek@cancer.dk
No publications or documents are linked to this record.
Start is estimated for Mar 2021; primary completion for Jul 2022, 16 months later.
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This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Soy isoflavones
Danish Cancer Society