Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

NCT06268665 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: UCDCC307NCI-2024-02360
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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; Ovarian Cancer Stage 1; Ovarian Cancer Stage IIIC; Breast Cancer Stage IIIA; Breast Cancer Invasive; Breast Cancer, Stage IA; Breast Cancer, Stage IB; Breast Cancer Stage IIB; Tumors, Breast; Mammary Cancer; Mammary Carcinoma; Breast Carcinoma; Breast Neoplasm; Malignant Breast Neoplasm; Malignant Tumor of Breast; Cancer of Ovary; Ovary Neoplasm; Breast Cancer Stage III; Breast Cancer Stage IV; Invasive Breast Cancer; Ovarian Cancer; Ovarian Cancer Stage II; Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Ovarian Cancer Stage IA; Ovarian Cancer Stage IB; Ovarian Cancer Stage IC; Ovarian Cancer Stage 2; Ovarian Cancer Stage 3; Ovarian Cancer Stage IIIb; Breast Cancer Stage IIA; Breast Cancer Stage IIIB; Breast Cancer Stage IIIc; Cancer, Breast; Ovary Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.

  Up to 1 year.

Secondary Outcomes (4)

• Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy.

  Up to 1 year.

• Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.

  Up to 1 year.

• Tolerability of daily intake of high-dose and low-dose tart cherry juice.

  Up to 1 year.

• Safety profile of daily intake of high-dose and low-dose tart cherry juice.

  Up to 1 year.

Study Arms (2)

Arm 1: High-Dose Tart Cherry Juice Supplement

EXPERIMENTAL

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

Drug: Tart Cherry Juice

Arm 2: Low-Dose Tart Cherry Juice Supplement

EXPERIMENTAL

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

Drug: Tart Cherry Juice

Interventions

Tart Cherry Juice DRUG

Given PO

Also known as: Juice extracted from Montmorency cherries, Juice from Prunus cerasus

Arm 1: High-Dose Tart Cherry Juice Supplement; Arm 2: Low-Dose Tart Cherry Juice Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95827, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Eve Rodler, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eve Rodler, MD

CONTACT

916-734-5959; erodler@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 20, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)