Trials / Recruiting
RecruitingNCT06268665
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | Tart Cherry Juice | Given PO |
Timeline
- Start date
- 2024-08-15
- Primary completion
- 2027-10-01
- Completion
- 2027-12-01
- First posted
- 2024-02-20
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06268665. Inclusion in this directory is not an endorsement.