Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Quality of Life; Bacterial Colonization; Radiation-induced Oral Mucositis
• Interventions: Drug: Mupirocin Ointment

• Registration Number: NCT05893810
• Lead Sponsor: Jiangxi Provincial Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-08
• Study Start: 2023-07-01
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Mupirocin Ointment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China