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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06268665
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • 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 Cancer, Stage IA
  • Breast Cancer, Stage IB
  • Breast Carcinoma
  • Breast Neoplasm
  • Cancer of Ovary
  • Cancer, Breast
  • Invasive Breast Cancer
  • Malignant Breast Neoplasm
  • Malignant Tumor of Breast
  • Mammary Cancer
  • Mammary Carcinoma
  • Ovarian Cancer
  • Ovarian Cancer Stage 1
  • Ovarian Cancer Stage 2
  • Ovarian Cancer Stage 3
  • Ovarian Cancer Stage IA
  • Ovarian Cancer Stage IB
  • Ovarian Cancer Stage IC
  • Ovarian Cancer Stage II
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IIIb
  • Ovarian Cancer Stage IV
  • Ovary Cancer
  • Ovary Neoplasm
  • Tumors, Breast

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tart Cherry Juice — DRUG
    Given PO

Study Details

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).

Key Dates

Start date
Aug 15, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: High-Dose Tart Cherry Juice Supplement
    1 oz tart cherry juice concentrate diluted in water up to 8oz.
  • Experimental: Arm 2: Low-Dose Tart Cherry Juice Supplement
    ¼ oz tart cherry juice concentrate diluted in water up to 8oz.

Primary Outcome 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. [ Time Frame: Up to 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95827
Eve Rodler, MD
[email protected]
916-734-5409
Eve Rodler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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