Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT00709020
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT00709020
Study Brief:
Protocol Section:
NCT00709020