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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07888907
- Acronym / sponsor ID
- DECORL / ICO-2025-28
- Conditions
- HNSCC
- Keywords
- Radiation dermatitis with moist desquamation, Bacterial decolonization, Staphylococcus aureus, Radiotherapy, Head and Neck Squamous Cell Carcinoma (HNSCC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacterial Decolonization | Experimental | Other: Bacterial decolonization, Other: Standard Hygiene MeasuresParticipants receive a bacterial decolonization |
| Standard Hygiene Measures | Active comparator | Other: Standard Hygiene MeasuresParticipants receive standard hygiene recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterial decolonizationParticipants receive a bacterial decolonization regimen + Standard Hygiene Measures | Other | Bacterial Decolonization |
| Standard Hygiene MeasuresParticipants receive standard hygiene recommendations | Other | Bacterial Decolonization, Standard Hygiene Measures |
Primary outcome
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.
Time frame: 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mélanie DORE, MD principal investigator
Institut de Cancérologie de l'Ouest (ICO)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie DORE, MD (+33 240679900, melanie.dore@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.