OncologyOEUVRENCT06959810
Impact of Adapted Aesthetic Onco in Patients With Upper Aerodigestive Tract Cancer During Their Management
A study testing Adapted Onco-Esthetics sessions in people with Oncology and Aerodigestive Tract Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Aerodigestive Tract Cancer, Suportive Care
- What is being tested?
- Adapted Onco-Esthetics sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2025to 15 Sep 2028
- 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
- Patient aged 18 or over
- Neoplastic location: oropharynx, oral cavity, hypopharynx, larynx, nasal cavity, salivary glands, cavum, sinus.
- Patient due to start oncological treatment (recurrence authorized)
- Patient fluent in French.
- Affiliation with a social security scheme
- Signature of informed consent prior to any specific procedure linked to the study
- Treatment with curative intent
Who cannot join
- Breast-feeding or pregnant patient
- Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
- Patient deprived of liberty, under guardianship, or subject to a legal protection measure or unable to express their consent.
- Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Francois Baclesse
Caen
Marielle RENOU, Care Manager, 33231455050, m.renou@baclesse.unicancer.fr
About this study
Official title: Impact of Adapted Aesthetic Onco in Patients With Cancer of the Upper Aero-digestive Tract During Their Management [ŒUVRE (Adapted Aesthetic Onco Aero-digestive Tract)]
Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's self-image.
Initial feedback from patients who have been able to benefit from adapted oncoesthetics (OEA) is overwhelmingly positive.
This study will assess the feasibility of oncoesthetics and describe any obstacles.
Read the detailed description
The majority of patients treated for VADS cancer come from disadvantaged socio-professional and family backgrounds. Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's self-image.
The French association for Oncological Support Care (SOS) defines socio-aesthetics as "the professional practice of aesthetic care adapted to people who are fragile or suffering as a result of an attack on their physical or psychological integrity, or in social distress". Priority patients for aesthetic care are those whose treatments have had an impact on body image (mutilating surgery, skin toxicities), and/or who are in a situation of social precariousness and suffer from a loss of self-esteem.
For patients suffering from VADS cancer, a population not usually in need of aesthetic care but in need of self-image restoration, an incentive program has been set up. Initial feedback from patients who have been able to benefit from adapted oncoesthetics (OEA) is overwhelmingly positive.
This study will assess the feasibility of OAS for VADS cancer patients, and describe any obstacles.
- Conditions
- Oncology, Aerodigestive Tract Cancer, Suportive Care
- Being tested
- Adapted Onco-Esthetics sessions
- Keywords
- Oncology (Organ: Upper Aero Digestive Tract), Supportive Oncology, Organization of care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Onco-Esthetics sessionsOther
Patient will received three sessions of Adapted Onco-Esthetics
| Study group | Role | What they receive |
|---|---|---|
| Three sessions of Adapted Onco-Esthetics | Experimental | Patients will received three sessions of Adapted Onco-Esthetics Receives: Other: Adapted Onco-Esthetics sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate, in patients treated for cancer of the upper aerodigestive tract, the impact of early treatment with Adapted Onco-Esthetics
Evaluation of the proportion of patients reporting no worsening of self-image representation, as measured by the BIS body image scale.
Measured: At each session (first , second and third). An interval of one to 4 weeks between 2 sessions is permitted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start24 Oct 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959810
- Sponsor's protocol ID
- OEUVRE
- Acronym
- OEUVRE
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adapted Aesthetic Onco in Patients With Cancer of the Upper Aero-digestive Tract During Their Management [ŒUVRE (Adapted Aesthetic Onco Aero-digestive Tract)]
- ClinicalTrials.gov ID
- NCT06959810
- Acronym / sponsor ID
- OEUVRE / OEUVRE
- Conditions
- Oncology, Aerodigestive Tract Cancer, Suportive Care
- Keywords
- Oncology (Organ: Upper Aero Digestive Tract), Supportive Oncology, Organization of care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Fondation de France, Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 7 May 2025 (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.
Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's self-image.
Initial feedback from patients who have been able to benefit from adapted oncoesthetics (OEA) is overwhelmingly positive.
This study will assess the feasibility of oncoesthetics and describe any obstacles.
Detailed description
The majority of patients treated for VADS cancer come from disadvantaged socio-professional and family backgrounds. Treatment for cancers of the pharyngolarynx is mutilating, with major consequences for patients' lives in terms of physical and functional after-effects. The psycho-social consequences are also significant, notably the metamorphosis of identity linked to the disease and its treatment, which alters the patient's self-image.
The French association for Oncological Support Care (SOS) defines socio-aesthetics as "the professional practice of aesthetic care adapted to people who are fragile or suffering as a result of an attack on their physical or psychological integrity, or in social distress". Priority patients for aesthetic care are those whose treatments have had an impact on body image (mutilating surgery, skin toxicities), and/or who are in a situation of social precariousness and suffer from a loss of self-esteem.
For patients suffering from VADS cancer, a population not usually in need of aesthetic care but in need of self-image restoration, an incentive program has been set up. Initial feedback from patients who have been able to benefit from adapted oncoesthetics (OEA) is overwhelmingly positive.
This study will assess the feasibility of OAS for VADS cancer patients, and describe any obstacles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three sessions of Adapted Onco-Esthetics | Experimental | Other: Adapted Onco-Esthetics sessionsPatients will received three sessions of Adapted Onco-Esthetics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged 18 or over
- Neoplastic location: oropharynx, oral cavity, hypopharynx, larynx, nasal cavity, salivary glands, cavum, sinus.
- Patient due to start oncological treatment (recurrence authorized)
- Patient fluent in French.
- Affiliation with a social security scheme
Key exclusion criteria (4 listed)
- Breast-feeding or pregnant patient
- Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
- Patient deprived of liberty, under guardianship, or subject to a legal protection measure or unable to express their consent.
- Patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.
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 |
|---|---|---|
| Adapted Onco-Esthetics sessionsPatient will received three sessions of Adapted Onco-Esthetics | Other | Three sessions of Adapted Onco-Esthetics |
Primary outcome
Evaluate, in patients treated for cancer of the upper aerodigestive tract, the impact of early treatment with Adapted Onco-Esthetics
Time frame: At each session (first , second and third). An interval of one to 4 weeks between 2 sessions is permitted
Evaluation of the proportion of patients reporting no worsening of self-image representation, as measured by the BIS body image scale.
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 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Onco-Esthetics sessions in people with Oncology and Aerodigestive Tract Cancer, run by Centre Francois Baclesse at 1 site 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Marielle RENOU, Care Manager (33231455050, m.renou@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate, in patients treated for cancer of the upper aerodigestive tract, the impact of early treatment with Adapted Onco-Esthetics (time frame: At each session (first , second and third). An interval of one to 4 weeks between 2 sessions is permitted). 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 12 Mar 2026.