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

NCT ID: NCT06268665

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1: High-Dose Tart Cherry Juice Supplement

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

Group Type: EXPERIMENTAL

Tart Cherry Juice

Intervention Type: DRUG

Given PO

Arm 2: Low-Dose Tart Cherry Juice Supplement

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

Group Type: EXPERIMENTAL

Tart Cherry Juice

Intervention Type: DRUG

Given PO

Interventions

Tart Cherry Juice

Given PO

Intervention Type: DRUG

Other Intervention Names

Juice extracted from Montmorency cherries; Juice from Prunus cerasus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eve Rodler

OTHER

Sponsor Role: lead

Responsible Party

Eve Rodler

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eve Rodler, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eve Rodler, MD

Role: CONTACT

erodler@ucdavis.edu

916-734-5959

Facility Contacts

Eve Rodler, MD

Role: primary

erodler@ucdavis.edu

916-734-5409

Other Identifiers

NCI-2024-02360

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCDCC307

Identifier Type: OTHER

Identifier Source: secondary_id

UCDCC307

Identifier Type: -

Identifier Source: org_study_id