tart cherry juice as a dietary supplement for the prevention of paclitaxel-induced neuropathy

Conditions: Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Stage IV; Invasive Breast Cancer; Ovarian Cancer; Ovarian Cancer Stage 1; Ovarian Cancer Stage II; Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Ovarian Cancer Stage IA; Ovarian Cancer Stage IB; Ovarian Cancer Stage IC; Ovarian Cancer Stage 2; Ovarian Cancer Stage 3; Ovarian Cancer Stage IIIb; Ovarian Cancer Stage IIIC; Breast Cancer Stage IIIA; Breast Cancer Invasive; Breast Cancer, Stage IA; Breast Cancer, Stage IB; Breast Cancer Stage IIA; Breast Cancer Stage IIB; Breast Cancer Stage IIIB; Breast Cancer Stage IIIc; Cancer, Breast; Tumors, Breast; Mammary Cancer; Mammary Carcinoma; Breast Carcinoma; Breast Neoplasm; Malignant Breast Neoplasm; Malignant Tumor of Breast; Cancer of Ovary; Ovary Cancer; Ovary Neoplasm

Summary: 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).

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.

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.