Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Jiangxi Provincial Cancer Hospital

Status and phase: Enrolling; Phase 3

Conditions: Bacterial Colonization; Radiation-induced Oral Mucositis; Quality of Life; Nasopharyngeal Carcinoma

Treatments: Drug: Mupirocin Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05893810

NPC-RIMO

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

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 radiation-induced oral mucositis(RIOM) and improve quality of life.

Treatment:

Drug: Mupirocin Ointment

Control

No Intervention group

Description:

Patients in the control arm will be treated according to standard of care.