White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00709020

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	Drug: white button mushroom extract Procedure: flow cytometry Procedure: high performance liquid chromatography Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: pharmacogenomic studies Procedure: pharmacological study	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label
Official Title:	A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2) [ Designated as safety issue: No ]
Serum sex steroid hormone levels [ Designated as safety issue: No ]
Optimal daily dose of WBM [ Designated as safety issue: No ]
Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry [ Designated as safety issue: No ]
Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays [ 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 [ Designated as safety issue: Yes ]
Effect of WBM on cytokines as measured by multiplex cytokine analyses [ Designated as safety issue: No ]
Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays [ Designated as safety issue: No ]
Barriers to recruitment of ethnically diverse patients from the community [ Designated as safety issue: No ]
Dietary sources of CUFA as measured by food frequency questionnaires [ Designated as safety issue: No ]
Bone metabolism markers (i.e., serum procollagen type-1 propeptide and urine N-telopeptide crosslinks) [ Designated as safety issue: No ]
Fasting lipids (i.e., total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

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

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

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Melanie R. Palomares, MD, MS 800-826-4673 mpalomares@coh.org
City of Hope Medical Group	Recruiting
Pasadena, California, United States, 91105
Contact: Steven Kohler, MD 626-396-2900

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Melanie R. Palomares, MD, MS

Beckman Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000599204, CHNMC-07213
Study First Received:	July 2, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00709020
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009