A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Arm 1: High-Dose Tart Cherry Juice Supplement
1 oz tart cherry juice concentrate diluted in water up to 8oz.
干预措施: Tart Cherry Juice (Drug)
Arm 2: Low-Dose Tart Cherry Juice Supplement
¼ oz tart cherry juice concentrate diluted in water up to 8oz.
干预措施: Tart Cherry Juice (Drug)
结局指标
主要结局
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.
时间窗: Up to 1 year.
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.
次要结局
- 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.(Up to 1 year.)
- Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.(Up to 1 year.)
- Tolerability of daily intake of high-dose and low-dose tart cherry juice.(Up to 1 year.)
- Safety profile of daily intake of high-dose and low-dose tart cherry juice.(Up to 1 year.)
研究者
Eve Rodler
Principal Investigator
University of California, Davis