Nasopharyngeal CarcinomaPhase 3NCT05893810
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis
A Phase 3 study testing Mupirocin Ointment in people with Nasopharyngeal Carcinoma and Radiation-induced Oral Mucositis, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Radiation-induced Oral Mucositis, Bacterial Colonization
- What is being tested?
- Mupirocin Ointment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed nasopharyngeal carcinoma
- No evidence of distant metastasis (M0)
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- 18-70 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Tianzhu Lu, 8615270186250, lutianzhu2008@163.com
Jingao Li
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Carcinoma, Radiation-induced Oral Mucositis, Bacterial Colonization, Quality of Life
- Being tested
- Mupirocin Ointment
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin OintmentDrug
Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mupirocin Ointment |
| Control | No intervention | Patients in the control arm will be treated according to standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-grade radiation-induced oral mucositis
Grade 3 or higher radiation-induced oral mucositis according to RTOG
Measured: 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
Grade 3 or higher radiation-induced dermatitis according to RTOG
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893810
- Sponsor's protocol ID
- NPC-RIMO
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37140904Liao 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.
PubMed 40773220
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment
- ClinicalTrials.gov ID
- NCT05893810
- Acronym / sponsor ID
- NPC-RIMO
- Conditions
- Nasopharyngeal Carcinoma, Radiation-induced Oral Mucositis, Bacterial Colonization, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Mupirocin OintmentThe 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. |
| Control | No intervention | –Patients in the control arm will be treated according to standard of care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly histologically confirmed nasopharyngeal carcinoma
- No evidence of distant metastasis (M0)
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- 18-70 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin OintmentPatients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares | Drug | Treatment Arm |
Primary outcome
High-grade radiation-induced oral mucositis
Time frame: 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
2 secondary outcomes
High-grade radiation dermatitis
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 37140904Kost 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.
- Derived from this study: PubMed 40773220Liao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mupirocin Ointment in people with Nasopharyngeal Carcinoma and Radiation-induced Oral Mucositis, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianzhu Lu, PhD (8615270186250, lutianzhu2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-grade radiation-induced oral mucositis (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.