Recruiting
Phase 2

Tart Cherry Juice

Sponsor:

UCLA

Code:

NCT06268665

Conditions

Breast Cancer

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Breast Cancer Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tart Cherry Juice

Study Details

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).

Conditions

Breast Cancer

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage III

Breast Cancer Stage IV

Study ID

NCT06268665

Start date

Aug 15, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: High-Dose Tart Cherry Juice Supplement

1 oz tart cherry juice concentrate diluted in water up to 8oz.

experimental: Arm 2: Low-Dose Tart Cherry Juice Supplement

¼ oz tart cherry juice concentrate diluted in water up to 8oz.

Interventions

Tart Cherry Juice

Given PO

Primary outcome measure

  • 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. [ Time Frame: Up to 1 year. ]

Central Contacts and Locations

Central contacts

Eve Rodler, MD

916-734-5959erodler@ucdavis.edu

Locations

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95827

Contacts

Eve Rodler, MD

916-734-5409erodler@ucdavis.edu

Principal Investigator:

Eve Rodler, MD

More Information

Sponsor

University of California, Davis

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-04.