An interventional study of Bacterial decolonization and Standard Hygiene Measures in HNSCC, sponsored by Institut Cancerologie de l'Ouest. Not yet recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Other
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.
Radiation dermatitis is a frequent and debilitating adverse effect of radiotherapy for head and neck cancers and may lead to treatment interruption or discontinuation. Effective preventive strategies remain limited.
This prospective randomized phase III trial will compare standard care alone with standard care plus a bacterial decolonization regimen in patients receiving curative-intent radiotherapy (≥66 Gy), with or without concomitant cetuximab or chemotherapy, for cancers of the upper aerodigestive tract.
The decolonization regimen includes chlorhexidine mouthwash before radiotherapy, chlorhexidine skin cleansing, and intranasal antibiotic ointment initiated before radiotherapy and repeated for 5 days every 15 days during treatment. Skin and nasal bacterial cultures will be collected at screening, on the first day of radiotherapy, and 7 days after completion of radiotherapy.
The primary endpoint is the incidence of grade 2 radiation dermatitis with moist desquamation assessed by blinded review of standardized photographs. Secondary endpoints include clinician-assessed radiation dermatitis, all grades of skin toxicity, systemic antibiotic use, premature radiotherapy discontinuation, correlation between bacterial colonization and skin toxicity, patient adherence to the decolonization regimen, and other radiation-related toxicities such as mucositis.
A total of 144 patients will be enrolled over 36 months. If successful, this study may establish bacterial decolonization as an effective preventive strategy for radiation-induced skin toxicity in head and neck cancer patients.
1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.
This study's planned enrollment of 144 is above the median of 50 across 1,456 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Institut Cancerologie de l'Ouest is the lead sponsor of 109 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Participants receive a bacterial decolonization
Other: Bacterial decolonization · Other: Standard Hygiene Measures
Participants receive standard hygiene recommendations
Other: Standard Hygiene Measures
Participants receive a bacterial decolonization regimen + Standard Hygiene Measures
Participants receive standard hygiene recommendations
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.
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
Time frame: 3 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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