HNSCCDECORLNCT07888907
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
A study testing Bacterial decolonization and Standard Hygiene Measures in people with HNSCC, run by Institut Cancerologie de l'Ouest at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC
- What is being tested?
- Bacterial decolonization and Standard Hygiene Measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2027to Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known hypersensitivity or allergy to chlorhexidine or mupirocin.
- Continuous long-term oxygen therapy (24 hours/day) via nasal cannula.
- Previous irradiation of the treatment area.
- 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).
- Use of photobiomodulation therapy as supportive care during radiotherapy and/or within 15 days after treatment completion.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Institut de Cancérologie de l'Ouest
Angers, 49055
Aurore GOINEAU, MD, Aurore.goineau@ico.unicancer.fr
CHU de Brest
Brest, 29000
Ulrike SCHICK, MD, ulrike.schick@chu-brest.fr
CHD Vendée
La Roche-sur-Yon, 85925
Marion RENOUF, MD, marion.renouf@ght85.fr
Clinique Victor Hugo
Le Mans, 72000
Yoann POINTREAU, MD, essaispointreau@ilcgroupe.fr
Centre Oscar Lambret
Lille, 59000
Xavier LIEM, MD, x-liem@o-lambret.fr
Centre Léon Bérard
Lyon, 69373
Séverine RACADOT, MD, severine.racadot@lyon.unicancer.fr
Clinique mutualiste de l'estuaire
Saint-Nazaire, 44600
Franck DROUET, MD, franck.drouet@hospigrandouest.fr
About this study
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)
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 the detailed description
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.
- Conditions
- HNSCC
- Being tested
- Bacterial decolonization, Standard Hygiene Measures
- Keywords
- Radiation dermatitis with moist desquamation, Bacterial decolonization, Staphylococcus aureus, Radiotherapy, Head and Neck Squamous Cell Carcinoma (HNSCC)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial decolonizationOther
Participants receive a bacterial decolonization regimen + Standard Hygiene Measures
Standard Hygiene MeasuresOther
Participants receive standard hygiene recommendations
| Study group | Role | What they receive |
|---|---|---|
| Bacterial Decolonization | Experimental | Participants receive a bacterial decolonization Receives: Other: Bacterial decolonization; Other: Standard Hygiene Measures |
| Standard Hygiene Measures | Active comparator | Participants receive standard hygiene recommendations Receives: Other: Standard Hygiene Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Mélanie DORE, MD, Principal investigator, Institut de Cancérologie de l'Ouest (ICO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888907
- Sponsor's protocol ID
- ICO-2025-28
- Acronym
- DECORL
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No