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Trial Title:
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis
NCT ID:
NCT05893810
Condition:
Nasopharyngeal Carcinoma
Radiation-induced Oral Mucositis
Bacterial Colonization
Quality of Life
Conditions: Official terms:
Nasopharyngeal Carcinoma
Mucositis
Stomatitis
Mupirocin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Mupirocin Ointment
Description:
Patients in the intervention arm will receive a decolonization regimen, consisting of
intranasal mupirocin ointment to be applied twice daily to the nares
Arm group label:
Treatment Arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianzhu Lu
Phone:
8615270186250
Email:
lutianzhu2008@163.com
Investigator:
Last name:
Jingao Li
Email:
Principal Investigator
Investigator:
Last name:
Zhaohui Liao
Email:
Sub-Investigator
Investigator:
Last name:
Xiaochang Gong
Email:
Sub-Investigator
Start date:
July 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Source:
Jiangxi Provincial Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05893810
