Tart Cherry + Fish Oil for Joint Pain

Recruiting at 1 trial location

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Philip Chang

Must be taking: AI therapy

Must not be taking: Anticoagulants, Analgesics, Steroids

Disqualifiers: Rheumatoid arthritis, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tart cherry and fish oil supplements together can reduce joint pain in breast cancer patients experiencing AIMSS, a type of joint pain caused by cancer treatment. The study will compare the effects of the combination to each supplement taken alone. Women with a BMI of 27 or higher who currently experience joint pain from AI therapy might be suitable for this study. The goal is to determine if these natural supplements can improve joint function, pain levels, and overall quality of life. As an Early Phase 1 trial, this research focuses on understanding how these supplements work in people, offering participants the chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are using anticoagulant medications or have recently changed your use of pain relievers or steroids.

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

Research shows that both tart cherry and fish oil are generally safe and easy for most people to use. Tart cherry, often taken as a supplement for joint health, usually has few side effects. Fish oil, rich in omega-3 fatty acids, is considered safe and helps reduce inflammation in conditions like rheumatoid arthritis. Studies have found that omega-3s can alleviate joint pain and are typically safe for most people. While researchers continue to study the combination of tart cherry and fish oil, both are known to have milder side effects compared to traditional medications for joint pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using tart cherry and fish oil for joint pain because these natural compounds may offer a novel approach compared to traditional treatments like NSAIDs or corticosteroids. Tart cherries are rich in antioxidants, which may reduce inflammation, while fish oil provides omega-3 fatty acids known to support joint health. This combination could offer a gentler option with fewer side effects, appealing to those seeking alternative or complementary therapies to standard medications. Additionally, the natural origin of these supplements might make them more accessible and appealing to individuals looking for holistic solutions.

What evidence suggests that this trial's treatments could be effective for joint pain?

Research has shown that omega-3 fatty acids in fish oil can reduce inflammation and ease symptoms like morning stiffness and joint pain. These benefits have appeared in conditions such as osteoarthritis and rheumatoid arthritis. Tart cherry concentrate also reduces inflammation, which may help with joint stiffness. In studies with mice, combining tart cherry and fish oil produced stronger anti-inflammatory effects than using each one alone, though this combination hasn't been tested in humans yet. In this trial, one group of participants will receive both tart cherry and fish oil to evaluate their combined effects on joint function and pain. Overall, both supplements have shown promise in improving joint function and reducing pain. ^{1 2 3 6 7}

Who Is on the Research Team?

Philip Chang, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with breast cancer stages I-III, currently on AI therapy, BMI ≥ 27, and experiencing joint pain from the treatment. They must have an Omega-3 Index <8%, a clinical diagnosis of AIMSS, and a certain level of joint pain. Excluded are those with stroke history, anticoagulant use, cherry or fish allergies, inflammatory joint diseases, recent changes in pain medication use or steroid use.

Inclusion Criteria

I am currently on aromatase inhibitor therapy.

You are considered overweight based on your height and weight.

I have been diagnosed with Stage I-III breast cancer.

Exclusion Criteria

You are allergic to cherries or fish/fish products.

I am currently taking blood thinner medications.

My diabetes is not under control, as determined by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tart Cherry and Omega-3 supplements for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Omega 3 FA (Fish Oil)
• Tart Cherry

Trial Overview The study tests if Tart Cherry concentrate combined with fish oil can reduce arthritis symptoms in obese breast cancer patients suffering from AIMSS during a 12-week period compared to a control group. It also looks at secondary outcomes like pain relief and quality of life improvements.

How Is the Trial Designed?

Group I: Group 2 : Tart Cherry and Omega 3 FA (Fish Oil) Experimental Treatment 2 Interventions

Group II: Group 1 : Wait list control Active Control 1 Intervention

No supplement but will be offered supplements after finishing the study

Who Is Running the Clinical Trial?

Philip Chang

Lead Sponsor

Trials

1

Recruited

30+

The Cherry Marketing Institute

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 51 patients with active rheumatoid arthritis, dietary supplementation with n-3 polyunsaturated fatty acids (n-3 PUFA) for 12 weeks led to small but significant improvements in morning stiffness, joint tenderness, and C-reactive protein levels.

The supplementation was found to be safe, with no serious side effects reported, although it only had a modest effect on a few disease variables and did not impact other traditional measures of disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. Faarvang, KL., Nielsen, GL., Thomsen, BS., et al.[2006]

In a clinical trial with 67 patients suffering from active rheumatoid arthritis, those receiving omega-3 fatty acids along with naproxen showed significant improvements in morning stiffness and overall health assessments compared to those on placebo and naproxen.

Patients who received omega-3 fatty acids alone experienced a deterioration in symptoms, but the deterioration was less severe when combined with naproxen, suggesting that omega-3 supplementation may enhance the effects of traditional anti-inflammatory medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. Kjeldsen-Kragh, J., Lund, JA., Riise, T., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06123286

Tart Cherry and Omega-3's for Aromatase Inhibitor ... Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues ...

2. withpower.com withpower.com/trial/early-phase-1-arthralgia-2024-239bf

Tart Cherry + Fish Oil for Joint Pain Research shows that omega-3 fatty acids found in fish oil can reduce inflammation and improve symptoms like morning stiffness and joint tenderness in people ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11174396/

Omega-3 Supplementation and Its Effects on Osteoarthritis Omega-3 polyunsaturated fatty acids (PUFA) have demonstrated an influential role in the progression of OA, resulting in the reduction of cartilage destruction.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304395907000413

A meta-analysis of the analgesic effects of omega-3 ... The results suggest that ω-3 PUFAs are an attractive adjunctive treatment for joint pain associated with rheumatoid arthritis, inflammatory bowel disease, and ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03855-w

Effect of omega-3 polyunsaturated fatty acids supplementation ... Pooled results showed that n-3 PUFAs supplementation could significantly relieve the arthritis pain as compared to placebo (standardized mean ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Omega 3 fatty acids overview for health professionals. Research health effects, dosing, sources, deficiency, side effects, and interactions here.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7362115/

The Effect of Omega-3 Fatty Acids on Rheumatoid Arthritis Omega-3 fatty acids seem to prevent or attenuate experimental arthritis. They may have a beneficial effect in the treatment of rheumatoid arthritis.