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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether high or low doses of tart cherry juice can help prevent nerve damage caused by paclitaxel chemotherapy. It is for adults with breast or ovarian cancer who plan to receive paclitaxel each week for 12 weeks. A random assignment places each person in a high-dose or low-dose group.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have invasive breast or ovarian cancer, stage I–IV, confirmed by a tissue test.
  • Plan to receive paclitaxel each week for 12 weeks. Certain other cancer treatments and joining other cancer studies are allowed.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Be able to answer questionnaires in English or Spanish, understand the study, and sign a consent form.
  • If able to become pregnant, agree to use birth control before and during the study, including treatment breaks, and for 3 months after the last juice dose, unless surgically sterilized.
  • If you have HIV, be on stable HIV treatment, need no antibiotics or antifungal drugs to prevent infections, and have a CD4 immune cell count above 250 and no detectable HIV on a blood test within the past year.
  • Agree not to drink any extra tart cherry juice or other cherry juice during the study.
  • Be able and willing to follow the study visit schedule and other study rules.

Who can't join

  • Past treatment with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum drugs. Doxorubicin is allowed after a break of at least 2 weeks.
  • Current or past peripheral neuropathy (nerve damage), or a long-term illness linked to it, such as diabetes, alcohol use disorder, or lupus.
  • Currently taking blood thinners.
  • Taking vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline, or duloxetine without agreeing to stop when signing up. Multivitamins with vitamin E are allowed, but vitamin E above 1,000 IU must be stopped.
  • Using cold therapy gloves to prevent nerve damage from chemotherapy.
  • A known cherry allergy or trouble swallowing liquids.
  • Being pregnant or breastfeeding. People producing breast milk must agree not to breastfeed while taking the study juice.
  • A condition that prevents understanding or giving consent, or that the study doctor believes could make participation unsafe or make study rules hard to follow.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA