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NCT06268665 | RECRUITING | Breast Cancer

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

Eve tobogganist

Information provided by (Responsible Party):

Eve tobogganist

Brief 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).

Condition or disease

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

Intervention/treatment

Tart Cherry Juice

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 86 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Actual Study Start Date : 2024-08-15
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
    Exclusion Criteria
    • * 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.
    • * Patients may not use cold therapy gloves for chemotherapy induced neuropathy.
    • * Known allergy to cherries.
    • * Inability to swallow liquid.
    • * Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).
    • * Any condition that would prohibit the understanding or rendering of informed consent.
    • * Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.
Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

Location Details

NCT06268665

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Locations

RECRUITING

United States, California

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95827