Trials / Unknown
UnknownNCT05893810
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- Jiangxi Provincial Cancer Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (RT) for patients with nasopharyngeal carcinoma, can prevent high-grade radiation-induced oral mucositis (RIOM) and improve quality of life. This study is being conducted because a randomized clinical trials form Yana Kost et al. have found bacterial decolonization in the nose prior to initiation of RT was effective for prevention of acute radiation dermatitis. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and mouth, and participants will also complete a quality of life questionnaire before and after RT.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mupirocin Ointment | Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-04-30
- Completion
- 2024-12-31
- First posted
- 2023-06-08
- Last updated
- 2024-02-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05893810. Inclusion in this directory is not an endorsement.