A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Summary
This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).
Detailed description
PRIMARY OBJECTIVE: I. Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. SECONDARY OBJECTIVE: I. Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. II. Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. III. Ascertain the tolerability and side effects of intake of high-dose and low-dose tart cherry juice OUTLINE: Tart cherry juice in both arms must begin ≤ 7 days from start of taxane therapy. During treatment, each participant in the high-dose group will consume 1 oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 196 oz). Each participant in the low-dose group will consume ¼ oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 49 oz). Participants will have follow-up visits at the conclusion of chemotherapy and at 12 months.
Arms & interventions
- DrugTart Cherry Juice
Given PO
Outcome measures
Primary
Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.
Time frame: Up to 1 year.
Secondary
Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.
Time frame: Up to 1 year.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
Time frame: Up to 1 year.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.
Time frame: Up to 1 year.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.
Time frame: Up to 1 year.
Eligibility criteria
Study locations (1)
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95827