This phase II trial tests how well tart cherry juice works to prevent peripheral nerve pain (neuropathy) in patients receiving paclitaxel for stage I-IV invasive breast or ovarian cancer. Paclitaxel is a type of taxane based chemotherapy. This type of chemotherapy often causes a side effect called peripheral neuropathy, which is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Tart cherry juice has been studied as a possible treatment for peripheral neuropathy because it has been shown to reduce inflammation in the body and is an “antioxidant.” Antioxidants are natural or man-made substances that may prevent or delay cell damage in the body. Previous research has shown that tart cherries have been associated with reducing pain, muscle damage and inflammation. Tart cherry juice may prevent the development of peripheral neuropathy in patients receiving paclitaxel for stage I-IV invasive breast or ovarian cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06268665.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Eve Therese Rodler
Phone: 916-734-5959
PRIMARY OBJECTIVE:
I. To evaluate the 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 at two different doses (“high-dose” and “low-dose”).
SECONDARY OBJECTIVES:
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. Assess the tolerability and safety profile of a daily intake of tart cherry juice.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive high-dose tart cherry juice orally (PO) twice daily (BID) beginning =< 7 days from the start of standard of care (SOC) paclitaxel and continuing for up to 14 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive low-dose tart cherry juice PO BID beginning =< 7 days from the start of SOC paclitaxel and continuing for up to 14 weeks in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up for up to 12 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorEve Therese Rodler