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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tart Cherry Juice

    Drug

    Given PO

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Arm 1: High-Dose Tart Cherry Juice SupplementExperimental treatment 1 intervention
Group B: Arm 2: Low-Dose Tart Cherry Juice SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Number of participants between study arms experiencing PIPN using the 11-item peripheral neuropathy component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) survey.

Time frame
Up to 1 year.

Secondary outcomes

1

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.

Assessment of the severity of PIPN using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) neuropathy subscale survey and National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v.5) physician assessment.

Time frame
Up to 1 year.
2

Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.

Number of participants between arms experiencing dose reductions, delays, or discontinuations.

Time frame
Up to 1 year.
3

Tolerability of daily intake of high-dose and low-dose tart cherry juice.

Number of participants between study arms ≥90% compliant with daily consumption of tart cherry juice.

Time frame
Up to 1 year.
4

Safety profile of daily intake of high-dose and low-dose tart cherry juice.

Number of participants between study arms with adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5).

Time frame
Up to 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov
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