NCT07888907Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
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)
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Mar 2030
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Diseases
- Head and neck cancer
- NCT number
- NCT07888907
What you commit to
- Study type: Interventional
- Planned participants: 144
- From Jan 2027 to the primary completion date, Mar 2030
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Clinique Victor Hugo Coordinator of this site? Confirm its status | Le Mans | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Clinique Mutualiste de l'Estuaire Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.