Staph Nasal Decolonization to Improve Function and Feeding

NCT07524894 | Not Yet Recruiting Phase 2

• 1 other identifier: SNIFF-ON-LHSC-001
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy is a type of treatment that involves using radiation beams targeted at a cancer to destroy the cancer cells or slow their growth. This type of treatment has helped many cancer patients for decades and is intended to kill cancer cells directly. Patients with head and neck cancer are commonly treated with radiation, sometimes after surgery and sometimes the radiation is delivered with chemotherapy at the same time. Radiation treatments have side effects, and the treating oncologist works with each patient to determine the best treatment and manage the side effects. It has been shown that one of these side effects of radiation is irritation or "sunburn" of the lining of the mouth and throat (radiation mucositis), which can cause difficult or painful swallowing, and pain/discomfort in the mouth/throat. These side effects can lead to dehydration, and weight loss, and sometimes can lead to hospital admissions and treatment delays. This is usually treated by the prescription of pain relievers, dietician support and, if necessary, nutrition via a tube (G-tube). Because of these symptoms involving the mouth and throat, researchers are looking to study the effect of a common ointment antibiotic used to reduce an infection known as Staphylococcus Aureus. The infection is commonly located in the front of the nose, and during treatment this infection can travel from the nose to the throat and worsen the radiation mucositis and the pain it causes. The study will measure if a course of ointment antibiotic in the nose (twice per day, 5 days on, 5 days off, repeated) can reduce your pain during treatment by reducing severe mucositis related to Staphylococcal infection. This study compares the effects of the study treatment with a "placebo," which looks the same but does not contain any active medicine. Neither you nor your doctor will know which one you are receiving until the study ends. The antibiotic used in the study arm is being used "off-label" for intranasal application (it is normally used to treat skin infections). Possible side effects include local skin irritation or allergic reactions, and in rare cases, a severe allergic response (anaphylaxis).

Conditions

Radiation Mucositis; Staphylococcal Aureus Infection; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Patient reported pain (Numeric rating scale (NRS) 0-10, validated 11-point tool for assessing pain intensity, ranging from 0 (no pain) to 10 (worst imaginable pain))

  Severity of pain in mouth or throat, measured on a 0-10 pain scale. Assessed weekly during treatment, using worst noted pain across treatment duration for analysis

  Measured weekly for duration of radiation treatment (Maximum 7 weeks)

Secondary Outcomes (6)

• Oral mucositis grade (Radiation Therapy Oncology Group scale 1-4 (Grade 1 (erythema/mild pain) to Grade 4 (severe necrosis/deep ulcerations requiring support))

  Weekly for duration of radiation (Max 7 weeks)

• Quality of life score

  Measured at treatment start and in final week of treatment (Max 7 weeks)

• Treatment interruptions

  Any treatment interruptions measured at weekly assessment (Max 7 weeks)

• Feeding tube insertion

  Any feeding tube insertion measured at weekly assessment (Max 7 weeks)

• Hospital admissions

  Any hospital admissions measured at weekly assessment (Max 7 weeks)

Study Arms (2)

Mupirocin topical ointment

EXPERIMENTAL

1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Drug: Mupirocin Ointment [Treatment]

Placebo Arm

PLACEBO COMPARATOR

1 fingertip unit of placebo petrolatum ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Drug: Placebo

Interventions

Mupirocin Ointment [Treatment] DRUG

1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Mupirocin topical ointment

Placebo DRUG

1 fingertip unit of topical petrolatum ointment (placebo) applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed mucosal squamous cell carcinoma of the head and neck, planned to receive a dose equivalent to 60 Gy in 30 fractions or higher, with or without concurrent systemic treatment. This can include hypofractionated regimens of 55 Gy in 20 fractions. Primary sites considered: oral cavity, oropharynx, larynx (excluding T1-T2N0 glottic cancers), hypopharynx. The radiotherapy treatment planned can be definitive or adjuvant.
• Age ≥18 years.
• ECOG performance status 0-2
• Informed consent provided.

You may not qualify if:

• Mupirocin allergy
• Skin or salivary gland malignancy
• Early stage glottic cancers (T1-2N0)

Sponsors & Collaborators

• David Palma: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• David Palma, MD PhD

  London Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niall O'Dwyer, MD

CONTACT

+1 5196858500; niall.odwyer@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a parallel-group, randomized, double-blinded trial. Patients will be randomised in a 1:1 ratio to either arm. Arm 1: Intranasal Mupirocin BID to each naris, applied twice daily, to be commenced in first week of treatment on 7-day on/7-day off cycle until completion of treatment. Arm 2: Placebo, matching intranasal ointment base, applied on same schedule as Arm 1.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documentation will be available beginning 6 months after publication of the primary results (or 12 months after study completion if no publication occurs), and will remain available for 5 years thereafter.
• Access Criteria: Access will be granted to qualified researchers who submit a written request with a brief protocol and analysis plan, and who sign a data sharing agreement approved by the sponsor-investigator. Approved requestors will receive a de-identified dataset containing the IPD described above and supporting documents (data dictionary, annotated case report forms, and the statistical analysis plan) via a secure institutional file-transfer platform; access is for research purposes only and data will not include direct identifiers.

Locations

CA (1)