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NCT00031551 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00031551 is a Phase 2 study that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 27 participants.
The verdict
NCT00031551, a Phase 2 study, was terminated before completion, sponsored by National Institute of Nursing Research (NINR).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study consisted of two parts: the pilot study and the main study. The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells in patients who have chemotherapy-related stomatitis. Main Study Description: Stomatitis is defined as inflammation of the mucous membranes of the oral cavity and oropharynx characterized by tissue erythema, edema, and atrophy, often progressing to ulceration. Stomatitis is a biologically complex, multifactorial, cancer treatment-related oral condition experienced by many oncology patients, which often leads to a cascade of negative sequelae including oropharyngeal pain, critical treatment alterations or cessation, and decreased quality of life. The optimal treatment strategies for stomatitis have not been established. There is a critical need to examine the pathogenesis of and to evaluate interventions for stomatitis and related acute oropharyngeal pain in the randomized controlled clinical trial setting using valid and reliable stomatitis assessment tools to both advance the science of cancer treatment-related oral toxicities and improve patient care. Therefore, the purpose of this randomized controlled clinical trial is to elucidate the role of inflammation in stomatitis by testing the effects of a novel tumor necrosis factor (TNF) fusion protein etanercept, (Enbrel, Immunex Corporation, Seattle, WA) on the incidence and severity of stomatitis. The actions of this fusion protein, which binds specifically to TNF preventing its interaction with cellular receptors and altering the inflammatory cascade, may provide insight into the role of inflammation in stomatitis. An etanercept effect is defined as a prevention or amelioration of stomatitis and acute oropharyngeal pain and/or changes in levels of tissue mediators. If stomatitis is primarily a consequence of a mucosal inflammatory response, then
Interventions
- DRUG Placebo
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2002-03 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031551
The ClinicalTrials.gov registry entry for NCT00031551 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00031551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00031551 about?
NCT00031551 is a clinical study titled "Evaluation of Efficacy and Mechanisms of an Antiinflammatory Intervention for Chemotherapy Related Mucosal Injury". This study consisted of two parts: the pilot study and the main study. The purpose of the pilot study is to demonstrate the effectiveness of planned laboratory techniques to assess for TNF-alpha gene expression from unstimulated saliva, plasma, and mucosal epithelial cells in patients who have chemo...
What is the current status of trial NCT00031551?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2002-03. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00031551?
The interventions under investigation include: Placebo (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00031551?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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