RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-08-15

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06268665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Eve Rodler, MD

CONTACT

916-734-5959

erodler@ucdavis.edu

Principal Investigator

Eve Rodler, MD

PRINCIPAL_INVESTIGATOR

University of California, Davis

Study Locations (Sites)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95827

United States

Collaborators and Investigators

Sponsor: Eve Rodler

Eve Rodler, MD, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15

Study Completion Date2027-12

Study Record Updates