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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
If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study
Patient elects to undergo active surveillance
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
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I agree not to take fish oil capsules if placed in the control group.
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I choose to monitor my condition without immediate treatment.
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I had a prostate biopsy with Dr. Mark using the Artemis and was diagnosed with adenocarcinoma.
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My prostate cancer has a Gleason score of 7 or less.
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My cancer is at an early stage and has not spread widely.
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I am willing to avoid lycopene, green tea, pomegranate supplements, and juice for a year.

Timeline

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
9%
Joint range of motion decreased
6%
Bloating
5%
Fatigue
3%
Headache
3%
Hot flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Placebo)
Arm I (Omega-3-fatty Acid)

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

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
25,969 Total Patients Enrolled
39 Trials studying Prostate Cancer
4,000 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,539 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,154 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
~6 spots leftby Nov 2024