Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

Bacterial decolonization: Participants receive a bacterial decolonization regimen + Standard Hygiene Measures

Standard Hygiene Measures: Participants receive standard hygiene recommendations

Study summary

Radiation dermatitis is a common and potentially treatment-limiting toxicity of radiotherapy for head and neck cancers. Colonization with Staphylococcus aureus has been identified as a risk factor for clinically significant radiation dermatitis, and bacterial decolonization has been shown to reduce moist desquamation in irradiated breast cancer patients. This randomized phase III trial evaluates whether a bacterial decolonization strategy can reduce the incidence of grade 2 radiation dermatitis with moist desquamation in patients receiving curative-intent radiotherapy (≥66 Gy) for cancers of the upper aerodigestive tract.

Eligibility

Primary outcome measure(s)

• Proportion of patients with at least one grade ≥2 radiation dermatitis event with moist desquamation occurring during radiotherapy and up to 15 days following radiotherapy completion. — 3 months
  The occurrence of grade ≥2 radiation dermatitis with moist desquamation will be assessed centrally and blinded by one radiation oncologist and one dermatologist using coded photographs of the face and neck (one frontal view and two profile views). Photographs will be obtained weekly throughout radiotherapy and up to 15 days after treatment completion for participants in both study arms

Trial sites (7)

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