Clinical trial NCT06268665: Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Official title: A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Up to 1 year.
Secondary outcomes:
measure: 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.
timeFrame: Up to 1 year.
measure: Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy.
timeFrame: Up to 1 year.
measure: Tolerability of daily intake of high-dose and low-dose tart cherry juice.
timeFrame: Up to 1 year.
measure: Safety profile of daily intake of high-dose and low-dose tart cherry juice.
timeFrame: Up to 1 year.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Davis
name: Eve Rodler, MD
role: PRINCIPAL_INVESTIGATOR
References: