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Tart Cherry Juice for Breast Cancer
Phase 2
Recruiting
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
Must not have
Active or history of peripheral neuropathy or associated chronic diseases
Currently taking anticoagulant medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year.
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had nerve damage or diseases related to it.
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I am currently on blood thinner medication.
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I am currently taking certain supplements or medications.
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I cannot swallow liquids.
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I have taken specific medications before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Eve RodlerLead Sponsor
Eve Rodler, MDPrincipal InvestigatorUniversity of California, Davis