White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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 dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)

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