Status:
COMPLETED
White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Cancer Survivor
Eligibility:
FEMALE
21+ years
Phase:
PHASE1
Brief Summary
RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors. PURPOSE: This phase I trial is studying the side effects and best...
Detailed Description
OBJECTIVES: 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 (B...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Prior diagnosis of infiltrating carcinoma of the breast ≥ 5 years prior to study entry
- Prior diagnosis of ductal carcinoma in situ
- No evidence of disease
- Completed all cancer therapy, with the exception of reconstructive surgery, at least 6 months prior to study entry
- Meets one of the following criteria:
- Normal mammogram within 1 year of study entry
- Underwent bilateral mastectomy and has been in remission for 5 years, as documented by an oncologist
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Postmenopausal, defined as any of the following:
- Continuous absence of menstruation for 12+ months
- Status post bilateral oophorectomy
- Status post hysterectomy with follicle-stimulating hormone in menopausal range
- Creatinine ≤ 1.5 times upper limit of normal (ULN) or less
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT \< 2 times ULN
- No allergy to mushrooms
- No personal history of any invasive cancer, other than breast cancer, or squamous cell or basal cell skin cancer
- No osteoporosis, defined as a bone-mineral density T-score of \< -2.5 on dual-energy x-ray absorptiometry scan
- No major systemic infections or other major medical illnesses of the cardiovascular, respiratory, or digestive system
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior and no concurrent hormone-modifying medications, including any of the following:
- Oral contraceptives
- Hormone replacement
- Selective estrogen receptor modifiers
- Other aromatase inhibitors
- Gonadotropic-releasing hormone modifiers
- At least 1 month since prior and no other concurrent mushroom extracts or DHEA as a dietary supplement
- No concurrent therapy, except continued medications for unrelated illness that are not excluded, and necessary medications for unrelated acute illnesses that may occur during the study (e.g., cold, flu, or infection)
- No more than 3 concurrent servings per week of the following foods:
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00709020
Start Date
June 1 2008
End Date
December 1 2010
Last Update
June 8 2015
Active Locations (2)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
City of Hope Medical Group
Pasadena, California, United States, 91105