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Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria. * Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment. * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed. * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed. * Concurrent use of immune checkpoint inhibitor therapy is allowed. * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed. * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed. * May participate concurrently in other cancer trials. * Must be able to complete questionnaires in English or Spanish. * Age ≥ 18 years old at the time of consent. * ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix). * Ability to understand and the willingness to sign a written informed consent document. * Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation). * Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have: * A stable regimen of highly active anti-retroviral therapy (HAART) * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections * A CD4 count above 250 cells/µL and an undetectable HIV viral load on standard PCR-based tests within the last year. * Stated willingness to not drink any additional tart cherry or any cherry juice while on the study. * Ability and willingness to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: * Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required). * Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus. * Currently taking anticoagulant medication. * Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements/medications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \> 1,000 international units (IU) must be discontinued at the time of registration. * Patients may not use cold therapy gloves for chemotherapy induced neuropathy. * Known allergy to cherries. * Inability to swallow liquid. * Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation). * Any condition that would prohibit the understanding or rendering of informed consent. * Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.
About the study
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).
What is being tested
- Tart Cherry Juice (drug)
Sponsor: University of California, Davis · Participants: 86 · Started: Aug 15, 2024
Contact the study team
- Eve Rodler, MD · Phone: 916-734-5959
Official record on ClinicalTrials.gov — NCT06268665
Locations in the U.S.
| California | University of California Davis Comprehensive Cancer Center, Sacramento |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.