Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Quality of Life Clinical Trial

Official title:

Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893810
• Other study ID #: NPC-RIMO
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Jiangxi Provincial Cancer Hospital
• Contact: Tianzhu Lu, PhD
• Phone: 8615270186250
• Email: lutianzhu2008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)