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).
• 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