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NCT01682031 · ClinicalTrials.gov registry record · Phase 2
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01682031: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT01682031 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01682031, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
Primary Outcome
Will be compared as difference in proportions with 95% confidence intervals.
Interventions
- OTHER placebo
- DRUG cisplatin
- PROCEDURE quality-of-life assessment
- RADIATION radiation therapy
- DIETARY_SUPPLEMENT selenomethionine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-06 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
Why NCT01682031 stopped before completion
NCT01682031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01682031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01682031 about?
NCT01682031 is a clinical study titled "Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy". This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherap...
What is the current status of trial NCT01682031?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2009-06. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01682031?
The interventions under investigation include: placebo (OTHER), cisplatin (DRUG), quality-of-life assessment (PROCEDURE), radiation therapy (RADIATION), selenomethionine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01682031?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01682031's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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