Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT06268665

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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A