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Disapproved by relevant Danish ethical committee
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lignan capsule | Experimental | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
|
| Isoflavones capsule | Experimental | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
|
| Placebo capsule | Placebo Comparator | 1 capsule/day from baseline to end-of-follow-up (approx. 4 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy isoflavones | Dietary Supplement | Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Apoptosis marker caspase-3 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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Data will be shared upon approval from relevant authorities and in accordance with the law
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Please request this information from PI Cecilie Kyrø, Ceciliek@cancer.dk
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| D017705 | Lignans |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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The study planned to include 150 women.
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| Lignans | Dietary Supplement | Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol) |
|
| Placebo | Dietary 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. |
|
| Change from baseline (diagnosis of breast cancer) to end-of-study (surgery): Approx. four months (neo-adjuvant setting) |
| 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) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |
| D001593 | Benzyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |