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

February 12, 2024 updated by: Eve Rodler

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95827
        • University of California Davis Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Eve Rodler, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: High-Dose Tart Cherry Juice Supplement
1 oz tart cherry juice concentrate diluted in water up to 8oz.
Drug: Tart Cherry Juice
Given PO
Other Names:
  • Juice extracted from Montmorency cherries
  • Juice from Prunus cerasus
Experimental: Arm 2: Low-Dose Tart Cherry Juice Supplement
¼ oz tart cherry juice concentrate diluted in water up to 8oz.
Drug: Tart Cherry Juice
Given PO
Other Names:
  • Juice extracted from Montmorency cherries
  • Juice from Prunus cerasus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Up to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Up to 1 year.
Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
Time Frame: Up to 1 year.
Number of participants between arms experiencing dose reductions, delays, or discontinuations.
Up to 1 year.
Tolerability of daily intake of high-dose and low-dose tart cherry juice.
Time Frame: Up to 1 year.
Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.
Up to 1 year.
Safety profile of daily intake of high-dose and low-dose tart cherry juice.
Time Frame: 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).
Up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eve Rodler

Investigators

  • Principal Investigator: Eve Rodler, MD, 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 Major Dates

Study Start (Estimated)

February 28, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCDCC307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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