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NCT03204266 · ClinicalTrials.gov registry record · Early Phase 1
Oral Supplementation to Enhance Recovery Pilot Study
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 46
- Enrollment target
NCT03204266: Completed Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03204266 is a Early Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 46 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03204266, a Early Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflammation and recovery for these surgical patients. This is an investigational study. Pro-Stat is not FDA-approved to treat any specific condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels. Their use to treat inflammation and help improve recovery after bladder cancer surgery is investigational. The study doctor can explain how the supplements are designed to work. Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
Participant compliance defined as "Yes" if a participant completes at least 16 out of the total 21 days' treatment.
Interventions
- DIETARY_SUPPLEMENT Omega-3 Fatty Acids
- DRUG Arginine recovery supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2017-08-16 |
| Est. Completion | 2022-05-25 |
| Phase | Early Phase 1 |
What the finished NCT03204266 record still lists
NCT03204266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Omega-3 Fatty Acids is the first listed.
NCT03204266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03204266 about?
NCT03204266 is a clinical study titled "Oral Supplementation to Enhance Recovery Pilot Study". The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflam...
What is the current status of trial NCT03204266?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 46 participants. The study started on 2017-08-16. Estimated completion is 2022-05-25.
What interventions are being tested in trial NCT03204266?
The interventions under investigation include: Omega-3 Fatty Acids (DIETARY_SUPPLEMENT), Arginine recovery supplement (DRUG).
Who is sponsoring clinical trial NCT03204266?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03204266's enrollment target sits among peer trials
46 566th of 2000 higher than 1,427 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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