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Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
Sponsor: Institut Cancerologie de l'Ouest
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.
Official title: A Phase III Trial Evaluating the Benefit of Bacterial Decolonization for the Prevention of Severe Radiation Dermatitis in Patients Treated With External Beam Radiotherapy for Head and Neck Squamous Cell Carcinoma (HNSCC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2027-01
Completion Date
2030-03
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Bacterial decolonization
Participants receive a bacterial decolonization regimen + Standard Hygiene Measures
Standard Hygiene Measures
Participants receive standard hygiene recommendations
Locations (7)
Institut de Cancérologie de l'Ouest
Angers, France
CHU de Brest
Brest, France
CHD Vendée
La Roche-sur-Yon, France
Clinique Victor Hugo
Le Mans, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Clinique mutualiste de l'estuaire
Saint-Nazaire, France