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Low-Fat Diet + Fish Oil for Prostate Cancer

N/A

Waitlist Available

Led By William Aronson

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate

Gleason grade 3+4 or less

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial will see if a low-fat diet with fish oil can help slow down disease progression in prostate cancer patients who are being actively monitored.

Who is the study for?

This trial is for men with prostate cancer who are on active surveillance, have a Gleason grade of 3+4 or less, and a PSA level under 20. They must not consume certain supplements or fish oil capsules during the study and be able to visit UCLA for check-ups. Men who've had prior prostate cancer treatments or take specific medications can't join.Check my eligibility

What is being tested?

The trial is testing if a low-fat diet combined with fish oil supplements can slow down prostate cancer progression in patients opting for active surveillance rather than immediate treatment.See study design

What are the potential side effects?

Potential side effects may include changes in digestion due to dietary adjustments and possible reactions to omega-3 fatty acids if there's an unknown allergy to fish products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a prostate biopsy with Dr. Mark using the Artemis and was diagnosed with adenocarcinoma.

Select...

My prostate cancer has a Gleason score of 7 or less.

Select...

My cancer is at an early stage and has not spread widely.

Select...

I am willing to avoid lycopene, green tea, pomegranate supplements, and juice for a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ki-67 index

Secondary outcome measures

Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count

Malignant Neoplasms

Biological Assay

+5 more

Side effects data

From 2014 Phase 3 trial • 262 Patients • NCT01385137

47%

Arthralgia

20%

Dyspepsia

15%

Diarrhea

10%

Nausea

Joint range of motion decreased

Bloating

Fatigue

Headache

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Omega-3-fatty Acid)

Arm II (Placebo)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (fish oil)Experimental Treatment3 Interventions

Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.

Group II: Arm I (control)Active Control1 Intervention

Patients receive no intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

omega-3 fatty acid

2013

Completed Phase 3

~730

behavioral dietary intervention

2000

Completed Phase 1

~750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,675 Total Patients Enrolled

39 Trials studying Prostate Cancer

3,982 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,264 Total Patients Enrolled

564 Trials studying Prostate Cancer

508,836 Patients Enrolled for Prostate Cancer

Pharmavite LLCIndustry Sponsor

9 Previous Clinical Trials

26,627 Total Patients Enrolled

Media Library

omega-3 fatty acid Clinical Trial Eligibility Overview. Trial Name: NCT02176902 — N/A

Prostate Cancer Research Study Groups: Arm I (control), Arm II (fish oil)

Prostate Cancer Clinical Trial 2023: omega-3 fatty acid Highlights & Side Effects. Trial Name: NCT02176902 — N/A

omega-3 fatty acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT02176902 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accessible to minors?

"This medical trial is open to people between the ages of 50 and 80 years old."

Answered by AI

Are there still openings available to participate in this research?

"According to public clinicaltrials.gov records, this trial is not actively seeking participants right now despite first being posted on November 1st 2014 and last updated April 4th 2022. On the other hand, 1259 different medical studies are still searching for volunteers at present."

Answered by AI

Would I meet the requirements to participate in this medical study?

"This oncological research is looking for 106 participants between the ages of 50 and 80 with prostate cancer. To qualify, those seeking to participate must agree to active surveillance, have a PSA score below 20, abstain from lycopene, green tea or pomegranate supplements/juice during the year-long study period and be close enough geographically to UCLA's Clinical Research Unit in order to make it there regularly."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer

2014. "Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02176902.

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