Staph Nasal Decolonization to Improve Function and Feeding

Condition(s) studied

Investigational drug(s) / intervention(s)

Mupirocin Ointment [Treatment]: 1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

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

Study 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).

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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