Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

NCT06446180

Oral Mucositis

COMPLETED PHASE1

Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

NCT06285591

Head and Neck Malignant Tumors

COMPLETED PHASE2

Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors

NCT05364918

Head and Neck Cancer

COMPLETED PHASE3

Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma

NCT02945878

Nasopharyngeal Neoplasms Stomatitis

UNKNOWN

Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis

NCT06968520

Head and Neck Tumors Metal Copper +1 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mupirocin Ointment

Intervention Type DRUG

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No