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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Given PO
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGEfficacy 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.
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.
Assessment of the severity of PIPN using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) neuropathy subscale survey and National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v.5) physician assessment.
Time frame: Up to 1 year.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
Number of participants between arms experiencing dose reductions, delays, or discontinuations.
Time frame: Up to 1 year.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.
Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.
Time frame: Up to 1 year.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.
Number of participants between study arms with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5).
Time frame: Up to 1 year.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.