Actively Recruiting
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Led by University of California, Davis · Updated on 2026-03-04
86
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.
- Planning to receive weekly paclitaxel chemotherapy for 12 weeks as part of neoadjuvant, adjuvant, or metastatic treatment.
- Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) allowed.
- Currently receiving hormone therapy, bisphosphonates, denosumab, or LHRH-agonists allowed.
- Concurrent use of immune checkpoint inhibitor therapy allowed.
- (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide allowed.
- Concurrent use of carboplatin with weekly paclitaxel allowed.
- May participate concurrently in other cancer trials.
- Ability to complete questionnaires in English or Spanish.
- Age 18 years or older at consent.
- ECOG performance status of 0 to 1 (Karnofsky scale 70% or higher).
- Ability and willingness to sign informed consent.
- Individuals of child-bearing potential must agree to use birth control before and during study participation and for 3 months after last dose, or be surgically sterilized.
- HIV-positive patients allowed if on stable anti-retroviral therapy, no antibiotics for opportunistic infections, CD4 count above 250 cells/µL, and undetectable viral load within the last year.
- Willingness to avoid any additional tart cherry or cherry juice during study.
- Ability and willingness to follow study schedule and requirements.
You will not qualify if you...
- Prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum (doxorubicin allowed with 2 week washout).
- Active or history of peripheral neuropathy or chronic diseases causing neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.
- Currently taking anticoagulant medication.
- Currently taking Vitamin E over 1000 IU, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline, or duloxetine (must stop if currently taking).
- Use of cold therapy gloves for chemotherapy-induced neuropathy not allowed.
- Known allergy to cherries.
- Inability to swallow liquids.
- Pregnant or breastfeeding (lactating individuals must agree not to breastfeed during juice supplementation).
- Any condition preventing understanding or signing informed consent.
- Any condition judged by the investigator to interfere with safety or compliance in the trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95827
Actively Recruiting
Research Team
E
Eve Rodler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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