Tart Cherry Juice for Breast Cancer

Overseen By Eve Rodler, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eve Rodler

Must be taking: Paclitaxel

Must not be taking: Anticoagulants, Vitamin E, others

Disqualifiers: Peripheral neuropathy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 14 weeks

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tart cherry juice to determine if it can prevent nerve damage caused by the chemotherapy drug paclitaxel in individuals with breast or ovarian cancer. Participants will be divided into two groups to receive either a high or low dose of the juice. The goal is to discover if tart cherry juice can reduce the tingling and numbness that some experience with this type of chemotherapy. Individuals with breast or ovarian cancer who plan to start paclitaxel chemotherapy and can drink cherry juice might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that most people can drink tart cherry juice without problems. Studies have found that tart cherries contain substances that may reduce swelling and act as antioxidants, benefiting health. Previous studies have not shown strong evidence of serious side effects. Most people consume tart cherry juice without major issues.

Tart cherry juice has been researched for its health benefits and is sold for various uses. So far, no major safety concerns have emerged. Overall, the juice is considered safe for most people when used as a supplement. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard breast cancer treatments, which often involve chemotherapy or hormone therapy, tart cherry juice stands out due to its natural origin and potential anti-inflammatory properties. Researchers are excited about tart cherry juice because it contains high levels of antioxidants, which may help reduce inflammation and oxidative stress, factors linked to cancer progression. The trial explores two different dosages of tart cherry juice concentrate, offering a unique approach to finding potentially effective, low-toxicity options for breast cancer management.

What evidence suggests that tart cherry juice could be effective for preventing peripheral neuropathy in breast cancer patients?

Research has shown that tart cherry juice contains substances like anthocyanins, which protect cells and reduce swelling. These benefits might help prevent nerve damage, which can cause numbness or pain, in cancer patients taking the drug paclitaxel. Although studies on human patients are limited, research on cells suggests that tart cherry juice could benefit those undergoing chemotherapy. This trial will compare the effects of high-dose and low-dose tart cherry juice supplements on these outcomes. ^{1 3 4 5 6}

Who Is on the Research Team?

Eve Rodler, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Known allergy to cherries

I have or had nerve damage or diseases related to it.

I am currently on blood thinner medication.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm 2: Low-Dose Tart Cherry Juice Supplement Experimental Treatment 1 Intervention

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

Group II: Arm 1: High-Dose Tart Cherry Juice Supplement Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Eve Rodler

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 not only delicious but also packed with bioactive compounds that may help prevent and manage chronic diseases like diabetes, cancer, and cardiovascular issues.

The high antioxidant potential of natural polyphenolic compounds in sweet cherries is likely responsible for their health benefits, although more clinical research is needed to fully understand these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel insights in health-promoting properties of sweet cherries. Faienza, MF., Corbo, F., Carocci, A., et al.[2021]

The sweet cherry extract, particularly from the Saco cultivar, showed significant anticancer properties by reducing the viability of both cancerous (LNCaP and PC3) and non-cancerous (PNT1A) prostate cells, indicating its potential as a therapeutic agent.

The extract enhanced apoptosis specifically in LNCaP cells and reduced oxidative damage and glycolytic metabolism, suggesting that sweet cherry extract may influence multiple cancer-related processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sweet Cherry Extract Targets the Hallmarks of Cancer in Prostate Cells: Diminished Viability, Increased Apoptosis and Suppressed Glycolytic Metabolism. Silva, GR., Vaz, CV., Catalão, B., et al.[2021]

In a 12-week randomized-controlled trial with 37 older adults, tart cherry juice significantly reduced systolic blood pressure and low-density lipoprotein (LDL) cholesterol levels, indicating potential cardiovascular benefits.

While tart cherry juice improved certain lipid profiles, it also led to increases in glucose, triglycerides, and body mass index (BMI), suggesting that further research is needed to fully understand its effects on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sweet Cherries as Anti-Cancer Agents: From Bioactive Compounds to Function. Fonseca, LRS., Silva, GR., Luís, Â., et al.[2023]

A meta-analysis of 10 randomized controlled trials involving 147 participants showed that tart cherry concentrate significantly improves endurance exercise performance when consumed 7 days to 1.5 hours before exercise, with a standardized mean difference of 0.36.

The benefits of tart cherry concentrate for endurance performance may be attributed to its low glycemic index, anti-inflammatory and antioxidant properties, and its ability to enhance blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis. Gao, R., Chilibeck, PD.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06268665

NCT06268665 | Tart Cherry Juice as a Dietary Supplement ... Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212429225017894

Tart cherry (Prunus cerasus L.): Polyphenols, Bioactivity, ... Producing the sour cherry pit oil nanoemulsion and evaluation of its anti-cancer effects on both breast cancer murine model and MCF-7 cell line.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296803/

Exploring the Epigenetic and Metabolic Pathways for ... Tart cherry (TC; Prunus cerasus) has high antioxidant and anti-inflammatory potentials due to its rich bioactive components like anthocyanins, ...

4. liebertpub.com liebertpub.com/doi/abs/10.1089/jmf.2011.0336

Tart Cherry Juice Induces Differential Dose-Dependent ... In this in vitro study, we tested the dose response of TCJ on CP and cell death in MCF-7 human breast cancer cells. TCJ was added at 0.03–30% (v/v) to cells and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8156356/

Sweet Cherries as Anti-Cancer Agents: From Bioactive ... Interestingly, an important anti-proliferative effect of sweet cherry extracts was observed in breast cancer cells, with no toxicity to the non-neoplastic MCF- ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-771/tart-cherry

Tart Cherry - Uses, Side Effects, and More Tart cherry fruit contains chemicals that might reduce swelling and act as antioxidants. Some tart cherry products are marketed for specific health purposes.