NCT06268665 Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
| NCT ID | NCT06268665 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Davis |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 86 participants in total. It began in 2024-08-15 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Eve Rodler, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT06268665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06268665 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06268665 currently recruiting?
Yes, NCT06268665 is actively recruiting participants. Contact the research team at erodler@ucdavis.edu for enrollment information.
Where is the NCT06268665 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT06268665 clinical trial?
NCT06268665 is sponsored by University of California, Davis. The principal investigator is Eve Rodler, MD at University of California, Davis. The trial plans to enroll 86 participants.
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