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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.

• Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.

‣ Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.

⁃ Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.

⁃ Concurrent use of immune checkpoint inhibitor therapy is allowed.

⁃ (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.

⁃ Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.

• May participate concurrently in other cancer trials.

• Must be able to complete questionnaires in English or Spanish.

• Age ≥ 18 years old at the time of consent.

• ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).

• Ability to understand and the willingness to sign a written informed consent document.

• Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).

• Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:

‣ A stable regimen of highly active anti-retroviral therapy (HAART)

⁃ No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections

⁃ A CD4 count above 250 cells/µL and an undetectable HIV viral load on standard PCR-based tests within the last year.

• Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.

• Ability and willingness to adhere to the study visit schedule and other protocol requirements

Locations
United States
California
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Contact Information
Primary
Eve Rodler, MD
erodler@ucdavis.edu
916-734-5959
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 86
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Eve Rodler

This content was sourced from clinicaltrials.gov