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?

Both Tart Cherry and Omega 3 FAs have better side effect profiles compared to other commonly used medications for AIMSS, such as nonsteroidal anti-inflammatories, steroids, and serotonin norepinephrine reuptake inhibitors. Additionally, in our clinics we often find that patients tend to be more receptive to taking a supplement as opposed to an additional medication. Further, both Tart Cherry concentrate and fish oil have beneficial properties for helping with joint stiffness in general, in addition to other health issues like insomnia. There is preliminary evidence in mouse models that when given together, these supplements may have an even greater anti-inflammatory effect than when taken separately14. Although to our knowledge, no human studies have tested this hypothesis. This study has been designed to test the hypothesis that Tart Cherry and fish oil when given in combination over a 12-week period could produce beneficial changes in joint function when compared to Tart Cherry or fish oil in isolation in an obese breast cancer population experiencing AIMSS. Secondary outcomes to be assessed include pain, functional performance, quality of life and cognition.

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 the combination of tart cherry and fish oil safe for humans?

Fish oil, which contains omega-3 fatty acids, is generally considered safe and has been shown to reduce inflammation in conditions like rheumatoid arthritis. However, specific safety data on the combination of tart cherry and fish oil is not available in the provided research. ^{1 2 3 4 5}

How does the Tart Cherry + Fish Oil treatment for joint pain differ from other treatments?

This treatment is unique because it combines tart cherry, known for its antioxidant properties, with fish oil, which contains omega-3 fatty acids that reduce inflammation. This combination may offer a novel approach to managing joint pain by addressing both inflammation and oxidative stress, unlike traditional treatments that often focus solely on inflammation. ^{1 2 6 7 8}

What evidence supports the effectiveness of the treatment 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 with rheumatoid arthritis, which is a type of joint pain. This suggests that fish oil might help with joint pain by reducing inflammation. ^{2 6 7 8 9}

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 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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fish oil attenuates persistent inflammatory pain in rats through modulation of TNF-α and resolvins. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of ω-3 polyunsaturated fatty acids on arthritic pain: A systematic review. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. [2013]

4. Denmark pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. [2006]

5. Italy pubmed.ncbi.nlm.nih.gov

[Fish oil supplementation in rheumatoid arthritis]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Inhibition of osteoporosis in autoimmune disease prone MRL/Mpj-Fas(lpr) mice by N-3 fatty acids. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

N-3 polyunsaturated fatty acids and inflammation: from molecular biology to the clinic. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Marine omega-3 fatty acids and inflammatory processes: Effects, mechanisms and clinical relevance. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Chronic oral or intraarticular administration of docosahexaenoic acid reduces nociception and knee edema and improves functional outcomes in a mouse model of Complete Freund's Adjuvant-induced knee arthritis. [2021]