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

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 partof neoadjuvant, adjuvant, or metastatic cancer treatment.

• Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.

• Currently receiving hormone therapy, bisphosphonates, denosumab orLHRH-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 consentdocument.

• Individuals of child-bearing potential must agree to use birth control (e.g.,hormonal or barrier method; abstinence, an intrauterine device) prior - to studyentry, for the duration of study participation (including dose interruptions), andfor 3 months after the last dose of tart cherry juice supplement; or be surgicallysterilized (e.g., hysterectomy or tubal ligation).

• Patients with known human immunodeficiency virus (HIV) are allowed in the study, butHIV-positive patients must have:

• A stable regimen of highly active anti-retroviral therapy (HAART)

• No requirement for concurrent antibiotics or antifungal agents for theprevention of opportunistic infections

• A CD4 count above 250 cells/µL and an undetectable HIV viral load on standardPCR-based tests within the last year.

• Stated willingness to not drink any additional tart cherry or any cherry juice whileon the study.

• Ability and willingness to adhere to the study visit schedule and other protocolrequirements

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 withperipheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemiclupus 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 thesesupplements/medications, they must agree to stop at the time of registration.Multivitamins containing Vitamin E are allowed, however Vitamin E > 1,000international 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 tobreast feed while taking study juice supplementation).

• Any condition that would prohibit the understanding or rendering of informedconsent.

• Any condition that in the opinion of the investigator would interfere with safety orcompliance while on trial.