Nasopharyngeal Carcinoma, Radiation-induced Oral Mucositis, Bacterial Colonization, Quality of Life
Conditions
Brief 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.
Interventions
Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed nasopharyngeal carcinoma 2. No evidence of distant metastasis (M0) 3. ECOG (Eastern Cooperative OncologyGroup) scale 0-1 4. 18-70 years old
Exclusion criteria
1. Previous or existing mental or cognitive impairment; 2. Patients with other malignant tumors at the same time; 3. Have received bacterial decolonization therapy; 4. Oral mucositis or ulcers existed before radiotherapy. 5. Prior RT to the region of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-grade radiation-induced oral mucositis | radiation-induced oral mucositis(graded by the RTOG) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) | Grade 3 or higher radiation-induced oral mucositis according to RTOG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-grade radiation dermatitis | Radiation dermatitis (graded by the CTCAE) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) | Grade 3 or higher radiation-induced dermatitis according to RTOG |
| Quality of Life according QLQ-H&N43 | Quality of Life (according QLQ-H&N43) will be assessed at the last treatment session (study week depends on patient's length of treatment, but ranges from 6 weeks to 8 weeks) | EORTC QLQ-H&N43 |
Countries
China
Contacts
Primary ContactTianzhu Lu, PhD
Outcome results
None listed