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

Phase 2

Recruiting

• Conditions: Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Ovarian Cancer; Breast Cancer Stage III; Ovarian Cancer Stage 1; Ovarian Cancer Stage II; Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Breast Cancer Stage IV
• Interventions: Drug: Tart Cherry Juice

• Registration Number: NCT06268665
• Lead Sponsor: Eve Rodler

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).

Detailed Description

PRIMARY OBJECTIVE: I. 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.

SECONDARY OBJECTIVE:

I. 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.

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

III. Ascertain the tolerability and side effects of intake of high-dose and low-dose tart cherry juice OUTLINE: Tart cherry juice in both arms must begin ≤ 7 days from start of taxane therapy. During treatment, each participant in the high-dose group will consume 1 oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 196 oz). Each participant in the low-dose group will consume ¼ oz of tart cherry juice twice per day for up to 14 weeks (maximum cumulative volume of 49 oz). Participants will have follow-up visits at the conclusion of chemotherapy and at 12 months.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-08
• Study Start: 2024-08-15
• Last Update Submitted: 2024-08-17
• Last Update Posted: 2024-08-20
• Primary Completion: 2027-10
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: High-Dose Tart Cherry Juice Supplement	Tart Cherry Juice	1 oz tart cherry juice concentrate diluted in water up to 8oz.
Arm 2: Low-Dose Tart Cherry Juice Supplement	Tart Cherry Juice	¼ oz tart cherry juice concentrate diluted in water up to 8oz.

Primary Outcome Measures

Name	Time	Method
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.	Up to 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Assessment of the severity of PIPN using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) neuropathy subscale survey and National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v.5) physician assessment.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.	Up to 1 year.	Number of participants between arms experiencing dose reductions, delays, or discontinuations.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.	Up to 1 year.	Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.	Up to 1 year.	Number of participants between study arms with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5).

Trial Locations

Locations (1)

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States