Mupirocin Ointment for Head and Neck Cancer

(SNIFF Trial)

NO
Overseen ByNiall O'Dwyer, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: David Palma
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Mupirocin Ointment, a common antibiotic ointment, can reduce pain and irritation in the mouth and throat for people undergoing radiation therapy for head and neck cancer. Radiation often causes side effects like painful swallowing and soreness, which can lead to serious issues such as dehydration and weight loss. Participants will receive either the antibiotic ointment applied to the nose or a placebo ointment to determine if the antibiotic can prevent a specific infection that might worsen these symptoms. Those with head and neck cancer, undergoing radiation treatment, and without a mupirocin allergy may be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that mupirocin ointment is generally safe. Most people tolerate it well when applied inside the nose. Common side effects are mild and may include skin irritation or an allergic reaction. Serious allergic reactions, such as anaphylaxis, are very rare. Mupirocin is approved for treating skin infections, indicating its safety for short-term use. However, long-term use might encourage the growth of germs that the ointment does not affect, such as certain fungi.12345

Why do researchers think this study treatment might be promising?

Unlike the standard of care for head and neck cancer, which typically involves surgery, radiation, and chemotherapy, mupirocin ointment offers a topical approach that could complement radiation therapy. Researchers are excited about mupirocin because it's a topical antibiotic that targets bacterial colonization in the nasal passages, potentially reducing infection risk during treatment. This method is unique because it's applied directly to the nares in a simple, cyclical fashion, which could enhance patient convenience and comfort. By focusing on infection control, this treatment might improve the overall effectiveness of existing cancer therapies and the patient's quality of life during treatment.

What evidence suggests that mupirocin ointment might be an effective treatment for radiation mucositis in head and neck cancer?

Research has shown that applying mupirocin ointment inside the nose can reduce severe mouth sores caused by radiation treatment in cancer patients. One study found it reduced serious mouth and throat swelling by more than half. Another study demonstrated a 25% decrease in severe cases of these painful sores. Patients reported less pain and found swallowing easier after using mupirocin. In this trial, participants will receive either mupirocin ointment or a placebo ointment to assess its effectiveness in alleviating the painful side effects of radiation therapy.12356

Who Is on the Research Team?

DP

David Palma, MD PhD

Principal Investigator

London Health Science Centre

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain head and neck cancers who are about to start radiation therapy, with or without chemo. Participants must be well enough for daily activities and cannot join if they have a mupirocin allergy, skin or salivary gland cancer, or early-stage glottic cancer.

Inclusion Criteria

Informed consent provided
I have head and neck squamous cell cancer and will get high-dose radiation treatment.
I am 18 years old or older.
See 1 more

Exclusion Criteria

Mupirocin allergy
I have cancer of the skin or salivary glands.
My glottic cancer is in an early stage (T1 or T2, no lymph node spread).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy, with either mupirocin or placebo ointment applied intranasally in a cyclical week on/off fashion

7 weeks
Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of oral mucositis, pain, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mupirocin Ointment

Trial Overview

The study tests whether using mupirocin antibiotic ointment in the nose can reduce mouth/throat pain during radiation by preventing staph infections. Patients get either the ointment or a placebo; neither patients nor doctors know which one until after the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Mupirocin topical ointmentExperimental Treatment1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Palma

Lead Sponsor

Trials
4
Recruited
530+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40773220/

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