Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

NCT05893810 | Unknown Phase 3

• 1 other identifier: NPC-RIMO
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Mupirocin Ointment DRUG

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed nasopharyngeal carcinoma
• No evidence of distant metastasis (M0)
• ECOG (Eastern Cooperative OncologyGroup) scale 0-1
• years old

You may not qualify if:

• Previous or existing mental or cognitive impairment;
• Patients with other malignant tumors at the same time;
• Have received bacterial decolonization therapy;
• Oral mucositis or ulcers existed before radiotherapy.
• Prior RT to the region of interest

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 37140904 BACKGROUND

• Liao Z, Xiong X, Zhao L, Zhang Z, Guan C, Zhang L, Zhong F, Rao J, Wang X, Xiao Y, Gong X, Huang SH, Li J, Lu T. Bacterial Decolonization With Mupirocin Ointment for Acute Radiation Oral Mucositis Prevention: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2025 Oct 1;11(10):1141-1149. doi: 10.1001/jamaoncol.2025.2361.

  PMID: 40773220 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Tianzhu Lu, PhD

CONTACT

8615270186250; lutianzhu2008@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 8, 2023
• Study Start: July 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)