Staph Nasal Decolonization to Improve Function and Feeding

Официальное название

Staph Nasal Decolonization to Improve Function and Feeding: A Randomized Clinical Trial (SNIFF)

Обзор

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).

Подробное описание

Radiation induced oral mucositis (RIOM) is a significant toxicity associated with curative head and neck radiotherapy leading to burdensome pain, weight loss, treatment interruptions and high healthcare utilisation. With contemporary treatment grade 3 or higher (CTCAE) oral mucositis rates occur in \~40% of all patients despite standardised oral care and supportive measures. There is growing evidence to implicate Staphylococcus aureus as a contributor to mucosal injury and symptom severity in this setting.

Skin and nasal carriage of S. aureus is common in the general population. In oncology patients auto-inoculation to the pharynx from the nose during treatment is biologically plausible. Intranasal antibiotics such as mupirocin are well-established, targeted decolonisation agents with a favourable safety profile when used intermittently, however their role in preventing severe radiation induced mucositis remains unknown.

Given RIOM typically emerges during weeks 2-3 of treatment and peaks towards the final treatment a cyclical short-course of intranasal or topical antibiotic regimen may sustain decolonisation across the vulnerable window while limiting continuous antibiotic exposure and potential resistance selection. The Centres for Disease Control and Protection recommend intranasal mupirocin when implementing decolonisation or pathogen reduction strategies for high risk patients during high risk periods.

A recent single-centre phase 3 randomised trial of 176 nasopharynx patients demonstrated a 25% reduction in grade 3 or higher oral mucositis rates when treated with cyclical nasal mupirocin decolonisation. This evidence led us to our research question- is this result applicable in a more generalised head and neck cancer population? SNIFF is a pragmatically designed randomised, placebo-controlled trial to test whether cyclical intranasal antibiotic reduces patient reported pain outcomes (NRS scale 0-10 measured weekly) due to reduction in rates of severe mucositis in patients receiving curative-intent head and neck radiotherapy (oral cavity, oropharynx, locally- advanced larynx, hypopharynx). The trial will also evaluate its effects on analgesia adjusted pain scores, physician reported mucositis rates patient reported quality of life (QOL) and rates of feeding tubes or treatment interruptions.

Please note: This trial will be run in a single centre (LHSC, London, Ontario)- the medication used in the experimental arm is topical Mupirocin 2% ointment, as the nasal form is not marketed in Canada. As the medication is being used off-label, we have applied to Health Canada via a Clinical Trial Application, and received a No-objection letter on Jan 14th 2026 (Health Canada control number 304222).

Вмешательства

• Препарат Mupirocin Ointment [Treatment]
  1 fingertip unit of topical mupirocin ointment applied BID to both nares in cyclical week on/off fashion throughout radiation treatment
• Препарат Placebo
  1 fingertip unit of topical petrolatum ointment (placebo) applied BID to both nares in cyclical week on/off fashion throughout radiation treatment

Первичные конечные точки

• 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)) [Срок оценки: Measured weekly for duration of radiation treatment (Maximum 7 weeks)]

Вторичные конечные точки (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)) [Срок оценки: Weekly for duration of radiation (Max 7 weeks)]
• Quality of life score [Срок оценки: Measured at treatment start and in final week of treatment (Max 7 weeks)]
• Treatment interruptions [Срок оценки: Any treatment interruptions measured at weekly assessment (Max 7 weeks)]
• Feeding tube insertion [Срок оценки: Any feeding tube insertion measured at weekly assessment (Max 7 weeks)]
• Hospital admissions [Срок оценки: Any hospital admissions measured at weekly assessment (Max 7 weeks)]
• Morphine adjusted pain score (MAPS) [Срок оценки: Measured weekly during radiotherapy treatment (Max 7 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• London Health Sciences Centre — London

Публикации

• 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

Идентификаторы

NCT: NCT07524894 · SNIFF-ON-LHSC-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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