protocolSection identificationModule nctId: NCT06268665, orgStudyIdInfo id: UCDCC307, briefTitle: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Eve Rodler, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, conditions: Breast Cancer Stage IV, conditions: Invasive Breast Cancer, conditions: Ovarian Cancer, conditions: Ovarian Cancer Stage 1, conditions: Ovarian Cancer Stage II, conditions: Ovarian Cancer Stage III, conditions: Ovarian Cancer Stage IV, conditions: Ovarian Cancer Stage IA, conditions: Ovarian Cancer Stage IB, conditions: Ovarian Cancer Stage IC, conditions: Ovarian Cancer Stage 2, conditions: Ovarian Cancer Stage 3, conditions: Ovarian Cancer Stage IIIb, conditions: Ovarian Cancer Stage IIIC, conditions: Breast Cancer Stage IIIA, conditions: Breast Cancer Invasive, conditions: Breast Cancer, Stage IA, conditions: Breast Cancer, Stage IB, conditions: Breast Cancer Stage IIA, conditions: Breast Cancer Stage IIB, conditions: Breast Cancer Stage IIIB, conditions: Breast Cancer Stage IIIc, conditions: Cancer, Breast, conditions: Tumors, Breast, conditions: Mammary Cancer, conditions: Mammary Carcinoma, conditions: Breast Carcinoma, conditions: Breast Neoplasm, conditions: Malignant Breast Neoplasm, conditions: Malignant Tumor of Breast, conditions: Cancer of Ovary, conditions: Ovary Cancer, conditions: Ovary Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Tart Cherry Juice, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy., secondaryOutcomes measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice., secondaryOutcomes measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California Davis Comprehensive Cancer Center, city: Sacramento, state: California, zip: 95827, country: United States, contacts name: Eve Rodler, MD, role: CONTACT, phone: 916-734-5409, email: erodler@ucdavis.edu, contacts name: Eve Rodler, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False