NCT00709020

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer
• Cancer Survivor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-07-03
• Last updated: 2015-06-08

Locations

2 sites across 1 country: United States