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Arm 2: Low-Dose Tart Cherry Juice Supplement for Breast Cancer

Phase 2

Waitlist Available

Led By Eve Rodler, MD

Research Sponsored by Eve Rodler

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria

Age ≥ 18 years old at the time of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year.

Awards & highlights

Study Summary

This trial is looking at whether tart cherry juice can help prevent nerve damage caused by certain chemotherapy drugs in breast and ovarian cancer patients. Participants will be randomly assigned to receive either a high dose or low dose

Who is the study for?

This trial is for breast and ovarian cancer patients about to undergo paclitaxel chemotherapy. Participants should not have any health conditions that exclude them from the study, but specific exclusion criteria are not listed here.Check my eligibility

What is being tested?

The study tests if tart cherry juice can prevent neuropathy caused by paclitaxel in two doses: high (Arm 1) and low (Arm 2). Patients will be randomly assigned to either group in equal numbers.See study design

What are the potential side effects?

While the side effects of tart cherry juice aren't specified, it's generally considered safe with possible mild digestive discomfort as a common side effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast or ovarian cancer is confirmed and staged.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I am scheduled to receive weekly paclitaxel for 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Low-Dose Tart Cherry Juice SupplementExperimental Treatment1 Intervention

¼ oz tart cherry juice concentrate diluted in water up to 8oz.

Group II: Arm 1: High-Dose Tart Cherry Juice SupplementExperimental Treatment1 Intervention

1 oz tart cherry juice concentrate diluted in water up to 8oz.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tart Cherry Juice

2008

Completed Phase 4

~70

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eve RodlerLead Sponsor

Eve Rodler, MDPrincipal InvestigatorUniversity of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently open?

"As per clinicaltrials.gov, recruitment for this particular study is presently inactive. The trial was initially publicized on February 28th, 2024 and last revised on February 12th, 2024. Despite the temporary closure of this trial, there are currently a substantial number of 7652 other studies open to participant enrollment."

Answered by AI

What are the safety considerations associated with Arm 2: Low-Dose Tart Cherry Juice Supplement for individuals?

"The safety assessment for Arm 2: Low-Dose Tart Cherry Juice Supplement has been rated a 2 by our team at Power. This rating reflects the Phase 2 trial status, indicating existing data on safety but lacking evidence of efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Eve Rodler 2024. "Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268665.

All > Neuropathy