Bacterial decolonization to prevent severe skin reactions from radiotherapy in head and neck cancer
Tests bacterial decolonization against skin damage from radiotherapy in people with head and neck cancer.
Plain-language title generated from the registry record
Registry title: Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
Key facts
- Where
- Angers, Brest, La Roche-sur-Yon, Le Mans, Lille, Lyon, and Saint-Nazaire, FranceSee the 7 sites
Where in France
- Institut de Cancerologie de L'OuestAngers, FranceNo longer taking part
- CHU de BrestBrest, FranceNo longer taking part
- CHD VendéeLa Roche-sur-Yon, FranceNo longer taking part
- Clinique Victor HugoLe Mans, FranceNo longer taking part
- Centre Oscar LambretLille, FranceNo longer taking part
- Centre Leon BerardLyon, FranceNo longer taking part
- Clinique Mutualiste de l'EstuaireSaint-Nazaire, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Cancerologie de l'Ouest
- Trial code
- NCT07888907
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Written informed consent obtained prior to the performance of any study-specific procedures; Patients scheduled to receive curative-intent cervical radiotherapy (minimum prescribed dose of 66 Gy using standard fractionation), with or without concomitant platinum-based chemotherapy and/or cetuximab, for upper aerodigestive tract cancer; Willingness to undergo photography of the irradiated areas at baseline, weekly during radiotherapy, and at 7 and 15 days after completion of radiotherapy; Patient covered by a health insurance plan.
Exclusion: Continuous long-term oxygen therapy (24 hours/day) via nasal cannula; Previous irradiation of the treatment area; Use of photobiomodulation therapy as supportive care during radiotherapy and/or within 15 days after treatment completion; Known hypersensitivity or allergy to chlorhexidine or mupirocin; Active chronic skin disease within the treatment field causing substantial skin changes and contraindicating the decolonization procedure, including severe inflammatory dermatoses (e.g., active psoriasis flare); Active chronic skin disease within the treatment field causing skin changes that could interfere with the accurate assessment of radiation dermatitis (e.g., severe psoriasis or extensive inflammatory dermatoses); Pregnant or breastfeeding women; Individuals deprived of liberty or under legal protection measures (guardianship, trusteeship, or equivalent legal protective supervision); Inability to comply with study follow-up requirements for geographic, social, or psychological reasons.