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

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).

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

Interventions

DRUG

Tart Cherry Juice

Given PO

Sponsors & Collaborators

• University of California, Davis

  lead OTHER

Principal Investigators

• Eve Rodler, MD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-15

Primary Completion

2027-10-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations