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

Launched by EVE RODLER · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether tart cherry juice can help prevent nerve damage (neuropathy) caused by a chemotherapy drug called paclitaxel, which is commonly used to treat breast and ovarian cancer. The trial involves giving participants either a high dose or a low dose of tart cherry juice while they undergo their treatment. The goal is to see if the juice can reduce the side effects that some patients experience from the chemotherapy.

To participate in this study, individuals must be diagnosed with invasive breast or ovarian cancer and be planning to receive paclitaxel for 12 weeks. Participants should be at least 18 years old and able to complete questionnaires in English or Spanish. They should not have a history of certain other treatments or conditions that could interfere with the study. If eligible, participants will be randomly assigned to one of the two groups and can expect to drink tart cherry juice during their treatment while attending regular check-ups to monitor their health. It’s important for potential participants to know that they should not consume any other cherry products during the study and must follow specific guidelines to ensure safety and compliance.

Gender

ALL

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.