Mupirocin Ointment for Head and Neck Cancer
(SNIFF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
David Palma, MD PhD
Principal Investigator
London Health Science Centre
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Treatment
Participants receive radiation therapy, with either mupirocin or placebo ointment applied intranasally in a cyclical week on/off fashion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of oral mucositis, pain, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Mupirocin Ointment
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment
1 fingertip unit of placebo petrolatum ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Palma
Lead Sponsor
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