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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00709020
First received: July 2, 2008
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cancer Survivor
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
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2) [ Time Frame: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment. ] [ Designated as safety issue: No ]
  • Serum sex steroid hormone levels [ Time Frame: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment. ] [ Designated as safety issue: No ]
  • Optimal daily dose of WBM [ Time Frame: 1 year after completion of the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 4 months after completion of treatment ] [ Designated as safety issue: Yes ]
  • Effect of WBM on cytokines as measured by multiplex cytokine analyses [ Time Frame: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins. ] [ Designated as safety issue: No ]
  • Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays [ Time Frame: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins. ] [ Designated as safety issue: No ]
  • Barriers to recruitment of ethnically diverse patients from the community [ Time Frame: 4 months after completion of treatment ] [ Designated as safety issue: No ]
  • Dietary sources of CUFA as measured by food frequency questionnaires [ Time Frame: Day -14 before treatment begins, day 1, 29, 57 and 85 after treatment begins ] [ Designated as safety issue: No ]
  • Bone metabolism markers (i.e., serum procollagen type-1 propeptide and urine N-telopeptide crosslinks) [ Time Frame: Day 1 of treatment and day 85 of treatment ] [ Designated as safety issue: No ]
  • Fasting lipids (i.e., total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) [ Time Frame: Day 1 of treatment and day 85 of treatment ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2008
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: White Button Mushroom Extract Drug: white button mushroom extract
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.
Other: flow cytometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
Other: high performance liquid chromatography
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
Other: laboratory biomarker analysis
Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.
Other: mass spectrometry
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
Other: pharmacogenomic studies
Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.
Other: pharmacological study
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.

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 (BCS).
  • To determine the optimal daily dose of WBM needed to induce aromatase inhibition of estrogen biosynthesis in these patients.
  • To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to moderate the anticancer effects of WBM.

Secondary

  • To determine the safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post-treatment comprehensive lipid panels.
  • To explore potential alternate antitumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity.
  • To describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention BCS trial utilizing a dietary supplement intervention in an effort to enhance feasibility of a subsequent phase II trial.

OUTLINE: This is a dose-escalation study.

Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable toxicity.

Patients undergo blood and urine sample collection at baseline and periodically during treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays; circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples are stored for post-trial pharmacogenomic studies.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709020

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Shiuan Chen, PhD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00709020     History of Changes
Other Study ID Numbers: 07213, P30CA033572, CHNMC-07213, CDR0000599204
Study First Received: July 2, 2008
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
cancer survivor
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014