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NCT03883828 · ClinicalTrials.gov registry record · Phase 2
Bacterial Decolonization to Prevent Radiation Dermatitis
A Phase 2 study of Radiation Dermatitis, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT03883828: Completed Phase 2 study of Radiation Dermatitis, sponsored by Montefiore Medical Center.
NCT03883828 is a Phase 2 study of Radiation Dermatitis that has completed, run by Montefiore Medical Center. The registered enrollment target is 80 participants, above the 34-participant average among 5 other Radiation Dermatitis trials with a reported enrollment target (135% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883828, a Phase 2 study of Radiation Dermatitis, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.
Primary Outcome
The number of high-grade radiation dermatitis events (grade 2-5) were assessed at the end of treatment. Instances of Grade 2-5 radiation dermatitis was assessed using photographs taken during the final radiation therapy visit. A blinded dermatologist viewed the images and assessed for toxicity grading using CTCAE Version 5.0 criteria.
Conditions Studied
Interventions
- DRUG Chlorhexidine gluconate solution
- DRUG Mupirocin Ointment
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2021-12-02 |
| Phase | Phase 2 |
What the finished NCT03883828 record still lists
NCT03883828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 34-participant average among 5 other Radiation Dermatitis trials with a reported enrollment target (135% higher).
The record links to 1 condition, with Radiation Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Chlorhexidine gluconate solution is the first listed.
NCT03883828 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03883828 about?
NCT03883828 is a clinical study titled "Bacterial Decolonization to Prevent Radiation Dermatitis". The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being condu...
What is the current status of trial NCT03883828?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-06-03. Estimated completion is 2021-12-02.
What conditions does trial NCT03883828 study?
This clinical trial studies the following conditions: Radiation Dermatitis.
What interventions are being tested in trial NCT03883828?
The interventions under investigation include: Chlorhexidine gluconate solution (DRUG), Mupirocin Ointment (DRUG).
Who is sponsoring clinical trial NCT03883828?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03883828 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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