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

NCT00709020 | Completed Phase 1 DMC

• 4 other identifiers: 07213P30CA033572CHNMC-07213CDR0000599204
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer; Cancer Survivor

Keywords

cancer survivor; breast cancer

Outcome Measures

Primary Outcomes (5)

• Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2)

  Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.

• Serum sex steroid hormone levels

  Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.

• Optimal daily dose of WBM

  1 year after completion of the study

• Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry

  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.

• Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays

  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.

Secondary Outcomes (7)

• Safety and tolerability of WBM as assessed by NCI CTCAE v3.0, symptom logs, bone metabolism markers, and pre- and post-treatment comprehensive lipid panels

  4 months after completion of treatment

• Effect of WBM on cytokines as measured by multiplex cytokine analyses

  Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.

• Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays

  Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.

• Barriers to recruitment of ethnically diverse patients from the community

  4 months after completion of treatment

• Dietary sources of CUFA as measured by food frequency questionnaires

  Day -14 before treatment begins, day 1, 29, 57 and 85 after treatment begins

Study Arms (1)

White Button Mushroom Extract

EXPERIMENTAL

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

Interventions

white button mushroom extract DRUG

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.

White Button Mushroom Extract

flow cytometry OTHER

Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.

White Button Mushroom Extract

high performance liquid chromatography OTHER

Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.

White Button Mushroom Extract

laboratory biomarker analysis OTHER

Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.

White Button Mushroom Extract

mass spectrometry OTHER

Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.

White Button Mushroom Extract

pharmacogenomic studies OTHER

Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.

White Button Mushroom Extract

pharmacological study OTHER

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.

White Button Mushroom Extract

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Flow Cytometry; Chromatography, High Pressure Liquid; Mass Spectrometry; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Chromatography, Liquid; Chromatography; Genetic Testing; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Shiuan Chen, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 3, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (2)