86 Participants Needed

Tart Cherry Juice for Breast Cancer

ER
Overseen ByEve Rodler, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eve Rodler
Must be taking: Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications if you join this trial. Specifically, you must stop taking anticoagulants, Vitamin E (over 1,000 IU), glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline, or duloxetine at the time of registration. Multivitamins with Vitamin E are allowed, but high doses of Vitamin E must be discontinued.

Is tart cherry juice safe for humans?

Tart cherry juice has been studied for its effects on blood pressure, cholesterol, and inflammation, showing some benefits without significant safety concerns. However, more research is needed to fully understand its long-term safety.12345

How does tart cherry juice differ from other breast cancer treatments?

Tart cherry juice is unique because it contains anthocyanins, which are natural compounds that may help induce cell death in breast cancer cells without affecting their growth. Unlike traditional cancer treatments, which often involve drugs or chemotherapy, tart cherry juice is a natural, dietary option that may offer additional health benefits, such as lowering blood pressure and cholesterol.13567

What is the purpose of this trial?

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).

Research Team

ER

Eve Rodler, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Patients with known HIV must meet specific criteria
My breast or ovarian cancer is confirmed and staged.
See 12 more

Exclusion Criteria

I have or had nerve damage or diseases related to it.
I am currently on blood thinner medication.
Known allergy to cherries
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose or low-dose tart cherry juice supplementation during paclitaxel chemotherapy

14 weeks
Regular visits during chemotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at the conclusion of chemotherapy and at 12 months

Treatment Details

Interventions

  • Tart Cherry Juice
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eve Rodler

Lead Sponsor

Trials
1
Recruited
90+

Findings from Research

In an in vitro study using MCF-7 human breast cancer cells, tart cherry juice (TCJ) demonstrated a biphasic effect on apoptosis, increasing cell death by apoptosis at 3% TCJ while decreasing it at 1% TCJ, indicating that the concentration of TCJ is crucial for its effects.
At concentrations of 10% and 30% TCJ, there was a significant reduction in cellular proliferation and an increase in necrosis, suggesting that higher doses of TCJ may lead to cell death through necrosis rather than apoptosis.
Tart cherry juice induces differential dose-dependent effects on apoptosis, but not cellular proliferation, in MCF-7 human breast cancer cells.Martin, KR., Wooden, A.[2022]
Tart cherry does not significantly affect blood pressure or heart rate, but it can reduce inflammation markers like serum C-reactive protein, with a moderate level of certainty based on 21 randomized controlled trials.
A dose-response analysis suggests that increasing the tart cherry dosage by 30 ml can lead to a reduction in C-reactive protein levels by approximately 0.19 mg/l, indicating that proper dosing is important for its anti-inflammatory effects.
Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials.Norouzzadeh, M., Hasan Rashedi, M., Shahinfar, H., et al.[2023]
Sweet cherries are rich in phenolic compounds that have been shown to suppress key processes involved in cancer development, such as oxidative stress and inflammation.
Research indicates that sweet cherries may also influence metabolic reprogramming related to cancer, suggesting their potential as a dietary supplement or therapeutic option in cancer treatment.
Sweet Cherries as Anti-Cancer Agents: From Bioactive Compounds to Function.Fonseca, LRS., Silva, GR., Luís, Â., et al.[2023]

References

Tart cherry juice induces differential dose-dependent effects on apoptosis, but not cellular proliferation, in MCF-7 human breast cancer cells. [2022]
Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials. [2023]
Sweet Cherries as Anti-Cancer Agents: From Bioactive Compounds to Function. [2023]
Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. [2021]
Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]
Sweet Cherry Extract Targets the Hallmarks of Cancer in Prostate Cells: Diminished Viability, Increased Apoptosis and Suppressed Glycolytic Metabolism. [2021]
Novel insights in health-promoting properties of sweet cherries. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security