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NOT YET RECRUITING
NCT07888907
NA

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

Sponsor: Institut Cancerologie de l'Ouest

View on ClinicalTrials.gov

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

OTHER

Bacterial decolonization

Participants receive a bacterial decolonization regimen + Standard Hygiene Measures

OTHER

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