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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Tart Cherry Juice
  Given PO

Первичные конечные точки

• 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. [Срок оценки: Up to 1 year.]

Вторичные конечные точки (4)

• 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. [Срок оценки: Up to 1 year.]
• Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. [Срок оценки: Up to 1 year.]
• Tolerability of daily intake of high-dose and low-dose tart cherry juice. [Срок оценки: Up to 1 year.]
• Safety profile of daily intake of high-dose and low-dose tart cherry juice. [Срок оценки: Up to 1 year.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California Davis Comprehensive Cancer Center — Sacramento

Идентификаторы

NCT: NCT06268665 · UCDCC307 · NCI-2024-02360 · UCDCC307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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