Clinical trial · Interventional
White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors
A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
NCT00709020CI-TRIAL-00018188completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Survivor | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| white button mushroom extract | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- White Button Mushroom Extract
- interventionNames
- Drug: white button mushroom extract
- Other: flow cytometry
- Other: high performance liquid chromatography
- Other: laboratory biomarker analysis
- Other: mass spectrometry
- Other: pharmacogenomic studies
- Other: pharmacological study
Primary outcomes (5)
- measure
- Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2)
- timeFrame
- Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
- measure
- Serum sex steroid hormone levels
- timeFrame
- Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.