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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Nasopharyngeal Carcinoma; Bacterial Colonization; Radiation-induced Oral Mucositis
• Intervention / Treatment: Drug: Mupirocin Ointment

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tianzhu Lu, PhD; Phone Number: 8615270186250; Email: lutianzhu2008@163.com

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
      • Principal Investigator: Jingao Li
      • Contact: Tianzhu Lu; Phone Number: 8615270186250; Email: lutianzhu2008@163.com
      • Sub-Investigator: Zhaohui Liao
      • Sub-Investigator: Xiaochang Gong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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.	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
No Intervention: Control; Patients in the control arm will be treated according to standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-grade radiation-induced oral mucositis	Grade 3 or higher radiation-induced oral mucositis according to RTOG	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-grade radiation dermatitis	Grade 3 or higher radiation-induced dermatitis according to RTOG	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)
Quality of Life according QLQ-H&N43	EORTC 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)

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital

Publications and helpful links

General Publications

• Kost Y, Deutsch A, Mieczkowska K, Nazarian R, Muskat A, Hosgood HD, Lin J, Daily JP, Ohri N, Kabarriti R, Shinoda K, McLellan BN. Bacterial Decolonization for Prevention of Radiation Dermatitis: A Randomized Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):940-945. doi: 10.1001/jamaoncol.2023.0444.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Mucositis; Stomatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin
• Other Study ID Numbers: NPC-RIMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No