White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors
NCT ID: NCT00709020
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2008-06-30
2010-12-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.
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Detailed Description
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Primary
* To show that a whole food extract of white button mushrooms (WBM) can inhibit aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer survivors (BCS).
* To determine the optimal daily dose of WBM needed to induce aromatase inhibition of estrogen biosynthesis in these patients.
* To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to moderate the anticancer effects of WBM.
Secondary
* To determine the safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post-treatment comprehensive lipid panels.
* To explore potential alternate antitumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity.
* To describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention BCS trial utilizing a dietary supplement intervention in an effort to enhance feasibility of a subsequent phase II trial.
OUTLINE: This is a dose-escalation study.
Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays; circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples are stored for post-trial pharmacogenomic studies.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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White Button Mushroom Extract
white button mushroom extract
Dose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day.
flow cytometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
high performance liquid chromatography
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
laboratory biomarker analysis
Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.
mass spectrometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
pharmacogenomic studies
Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.
pharmacological study
Performed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
Interventions
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white button mushroom extract
Dose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day.
flow cytometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
high performance liquid chromatography
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
laboratory biomarker analysis
Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.
mass spectrometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
pharmacogenomic studies
Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.
pharmacological study
Performed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
Eligibility Criteria
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Exclusion Criteria
* Flaxseeds and flaxseed meal
* High-energy bars or diet bars containing soy or soy protein
* Liquid-nutrition drinks containing soy or soy protein (e.g., Odwalla Future Shake or Ensure Plus)
* Miso soup
* Natto
* Packaged mixed dishes with soy or tofu (e.g., lasagna, burritos, or stir-fry)
* Cooked soybeans or edamame (i.e., green soybeans)
* Roasted soy nuts
* Soymilk, regular or low-fat, plain or flavored
* Soy cheese, such as cheddar, mozzarella, cram cheese, or parmesan (includes all foods made with soy cheese)
* Soy protein powders (e.g., performance or body-builder powders)
* Soy yogurt, all types
* Soy sauce, tamari, teriyaki sauce, Szechuan sauce, or hoisin sauce
* Soy ice cream, tofutti, or other soy desserts
* Tempeh, all types
* Tofu, all types, including low-fat, flavored, marinated, and smoked
* Tofu or soy breakfast sausage, bacon, or other breakfast meat
* Tofu or soy cold cuts, hot dogs, or other deli meat substitutes
* Veggie soy or tofu burger, ground meat substitute (texturized vegetable protein), or soy or tofu, chicken, or turkey
* Concurrent supplemental calcium and/or vitamin D and bisphosphonates allowed provided doses remain constant throughout the run-in and treatment portions of the trial
21 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Shiuan Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Countries
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Other Identifiers
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CHNMC-07213
Identifier Type: -
Identifier Source: secondary_id
CDR0000599204
Identifier Type: REGISTRY
Identifier Source: secondary_id
07213
Identifier Type: -
Identifier Source: org_study_id
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