Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (37)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Invasive | — | UNRESOLVED | — |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer, Stage IA | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer, Stage IB | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IIA | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage IIB | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tart Cherry Juice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: High-Dose Tart Cherry Juice Supplement
- description
- 1 oz tart cherry juice concentrate diluted in water up to 8oz.
- interventionNames
- Drug: Tart Cherry Juice
- type
- EXPERIMENTAL
- label
- Arm 2: Low-Dose Tart Cherry Juice Supplement
- description
- ¼ oz tart cherry juice concentrate diluted in water up to 8oz.
- interventionNames
- Drug: Tart Cherry Juice
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available