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

Breast Cancer Clinical Trial

Official title:
A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Breast Cancer
  • Breast Cancer Invasive
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage IIA
  • Breast Cancer Stage IIB
  • Breast Cancer Stage III
  • Breast Cancer Stage IIIA
  • Breast Cancer Stage IIIB
  • Breast Cancer Stage IIIc
  • Breast Cancer Stage IV
  • Breast Carcinoma
  • Breast Neoplasm
  • Breast Neoplasms
  • Cancer of Ovary
  • Cancer, Breast
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Invasive Breast Cancer
  • Malignant Breast Neoplasm
  • Malignant Tumor of Breast
  • Mammary Cancer
  • Mammary Carcinoma
  • Neoplasms
  • Ovarian Cancer
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IIIb
  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IV
  • Ovarian Neoplasms
  • Ovary Cancer
  • Ovary Neoplasm
  • Tumors, Breast
Clinical Trial Details
NCT number NCT06268665
Study type Interventional
Source University of California, Davis
Contact Eve Rodler, MD
Phone 916-734-5959
Email erodler@ucdavis.edu
Status Not yet recruiting
Phase Phase 2
Start date February 28, 2024
Completion date June 2027
View Details
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