Health Trials

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

ConditionsBreast CancerBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage IIIBreast Cancer Stage IVInvasive Breast CancerOvarian CancerOvarian Cancer Stage 1Ovarian Cancer Stage IIOvarian Cancer Stage IIIOvarian Cancer Stage IVOvarian Cancer Stage IAOvarian Cancer Stage IBOvarian Cancer Stage ICOvarian Cancer Stage 2Ovarian Cancer Stage 3Ovarian Cancer Stage IIIbOvarian Cancer Stage IIICBreast Cancer Stage IIIABreast Cancer InvasiveBreast Cancer, Stage IABreast Cancer, Stage IBBreast Cancer Stage IIABreast Cancer Stage IIBBreast Cancer Stage IIIBBreast Cancer Stage IIIcCancer, BreastTumors, BreastMammary CancerMammary CarcinomaBreast CarcinomaBreast NeoplasmMalignant Breast NeoplasmMalignant Tumor of BreastCancer of OvaryOvary CancerOvary Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).

Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.

Currently taking anticoagulant medication.

Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements/medications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E > 1,000 international units (IU) must be discontinued at the time of registration.

Trial design

Treatments tested in this trial

  • Tart Cherry Juice

Treatment groups

86 Participants
are divided into 2 treatment groups

Locations

1
University of California Davis Comprehensive Cancer Center95827, SacramentoCalifornia, United States

Sponsors and collaborators

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov