Oral Mucositis (Ulcerative)NéoPBMNCT07054528
Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
An observational study of Oral Mucositis (Ulcerative) and Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
Most patients with cancer or haematological malignancies who receive chemotherapy - broadly defined to include targeted therapies and immunotherapy - and/or external beam radiotherapy may experience serious and disabling adverse events related to these treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Oral Mucositis (Ulcerative) Due to Radiation
- How many people
- 33,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2025to 30 Oct 2034
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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
Study population: Most patients with cancer or haematological malignancies receiving chemotherapy and presenting with oral mucositis and/or radio- and/or chemo-induced dermatitis will have some form of oral mucositis.
Who may be able to join
- Any adult patient over 18 years of age
- Patient treated with the CareMin650™ photobiomodulation device, as a preventive or curative measure for oral mucositis and/or radiodermatitis induced by chemotherapy (in the broadest sense: includes targeted therapies, immunotherapy) and/or radiotherapy, as part of their routine management for any type of cancer or haematological malignancy, whatever the stage and prognosis of the disease
- Information note sent to the patient and record of the patient's or legal representative's (guardian's) non-objection
- Membership of a social security scheme
Who cannot join
- Pregnant women
- Patient with severe cognitive impairment rendering him/her incapable of expressing non-objection to participation in the study.
- If the patient is under guardianship or curatorship: objection from the guardian/curator.
- Patient with a known allergy to polyurethane
- Patient taking part in a clinical study involving medicinal or non-medicinal therapies to treat or prevent oral mucositis or radiodermatitis.
- Patients physically unable to apply Ora-Pad and Derma-Pad devices (e.g. limited mouth opening).
Trial locations and contacts
1 site in 1 country.
About this study
Most patients with cancer or haematological malignancies who receive chemotherapy - broadly defined to include targeted therapies and immunotherapy - and/or external beam radiotherapy may experience serious and disabling adverse events related to these treatments.
Mucositis and radiodermatitis are a frequent and disabling complication of cancer and haematological malignancy treatments: chemotherapy (in the broadest sense: includes immunotherapy, targeted therapies) and/or radiotherapy, having a considerable impact on patients' quality of life.
Read more
Mucositis is linked to lesions that occur in epithelial and connective tissues in response to a complex cascade of biological events involving the cellular elements of the mucosa.
All these consequences make for an inadequate care pathway (hospitalisations and urgent care, complications, decompensations of comorbidities) and considerably increase the financial cost of patient care. Management strategies are perfectly codified, and photobiomodulation is now recommended internationally with a high level of evidence for the prevention and treatment of oral mucositis and radiodermatitis.
Photobiomodulation (PBM), previously known as low-level laser therapy, has been used for decades in numerous therapeutic indications, based on major scientific knowledge and significant scientific and technological developments Including in fields such as aerospace or military medicine.
CareMin650™ is a photobiomodulation medical device marketed since 2020 and indicated for the treatment of oral mucositis and radiodermatitis.
The aim of the registry is to describe the real-life use of CareMin650™ in France in the preventive and curative treatment of radio and/or chemo-induced oral mucositis and radiodermatitis.
- Conditions
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Oral Mucositis (Ulcerative) Due to Radiation, Dermatitis
- Keywords
- Oncology, Photobiomodulation, oral mucositis, dermatitis, chemotherapy, radiotherapy
- Medical subject headings
- Stomatitis, Ulcer, Dermatitis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the evolution of the severity of radio- and/or chemo-induced oral mucositis lesions and radiodermatitis during preventive or curative treatment with CareMin650™ between the first and last session.
- Grading of lesions according to WHO scales for oral mucositis 0 - No lesion 1 - Erythema - moderate pain 2 - Moderate ulceration - solid food 3- Severe ulceration - liquid food 4 - Severe ulceration - no oral feeding
- Grading of lesions according to WHO scales for radiodermatitis 0 - No lesion
- - Mild erythema or dry desquamation
- - Moderate to vivid erythema - localized moist desquamation in folds - moderate edema
- - Localized moist desquamation other than in folds - minor bleeding due to light trauma or abrasion
- - Ulceration or necrosis - spontaneous bleeding - indication for grafting
Measured: Measured at the first of photobiomodulation and at the last session (Week 12)
Secondary outcomes (4)
Assessment of the satisfaction of professionals using the CareMin650™
Assessment of the satisfaction of CareMin650™ users (nurses, doctors, radio manipulators) :
- Ease of device installation (4-point Likert scale)
- Very satisfactory
- Somewhat satisfactory
- Rather unsatisfactory
- Not at all satisfactory
- Conditions for programming the device (4-point Likert scale) How did the installation of the device go?" "Very easy"; "Rather easy", "Rather difficult"; "Very difficult".
- Overall assessment of device ergonomics (ease of use) (4-point Likert scale) In your opinion, using the device is " " Very convenient " ; " Rather convenient " ; " Rather inconvenient " ; " Not at all convenient "
Measured: At last photobiomodulation session Week 12
Assessment of patient satisfaction
Assessment of patient satisfaction following CareMin650™ sessions:
- Level of constraint related to PBM (4-level Likert scale)
- Existence of pain when applying the device (4-point Likert scale)
- Discomfort during sessions (4-point Likert scale)
- Overall satisfaction with duration of sessions
Measured: At last photobiomodulation session week12
Description of the conditions of real-life use of CareMin650™
Description of the conditions of real-life use of CareMin650™ :
- Therapeutic objective
- Nature of carer carrying out PBM treatment
- Average number of sessions performed per week
- Total number of sessions performed
- Administration before, during or after chemotherapy and/or radiotherapy
- Dose prescribed according to therapeutic objective (preventive/curative)
- Used alone or in combination with another PBM device
Measured: At last session of photobiomodulation week 12
Assessment of the clinical benefit of CareMin650™ in the management of oral mucositis for the patient
Assessment of the clinical benefit of CareMin650™ in the management of oral mucositis for the patient / QUESTIONNAIRES ABOUT :
- Ability to feed: solid and liquid oral nutrition, liquid/semi-liquid oral nutrition, enteral tube feeding
- Medicinal treatments for oral mucositis (type of treatment, dosage, duration)
- Related medicinal treatments, in particular analgesics and psychotropic drugs (nature of treatments, names of molecules, dosages, duration of treatment, and possible modifications during photobiomodulation treatment)
- Evaluation of oral pain by Visual Analogue Scale before and after each session
- Duration of each session
Measured: At last session of photobiomodulation week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start20 Jun 2025
- Primary completion30 Oct 2034 (estimated)
- Study completion30 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33,000 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054528
- Sponsor's protocol ID
- 2024-03-01
- Acronym
- NéoPBM
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2025
- Last updated
- 9 Feb 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
- ClinicalTrials.gov ID
- NCT07054528
- Acronym / sponsor ID
- NéoPBM / 2024-03-01
- Conditions
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Oral Mucositis (Ulcerative) Due to Radiation, Dermatitis
- Keywords
- Oncology, Photobiomodulation, oral mucositis, dermatitis, chemotherapy, radiotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 30 Oct 2034 (estimated)
- Study completion
- 30 Oct 2034 (estimated)
- First posted
- 8 Jul 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.
Most patients with cancer or haematological malignancies who receive chemotherapy - broadly defined to include targeted therapies and immunotherapy - and/or external beam radiotherapy may experience serious and disabling adverse events related to these treatments.
Mucositis and radiodermatitis are a frequent and disabling complication of cancer and haematological malignancy treatments: chemotherapy (in the broadest sense: includes immunotherapy, targeted therapies) and/or radiotherapy, having a considerable impact on patients' quality of life.
Mucositis is linked to lesions that occur in epithelial and connective tissues in response to a complex cascade of biological events involving the cellular elements of the mucosa.
All these consequences make for an inadequate care pathway (hospitalisations and urgent care, complications, decompensations of comorbidities) and considerably increase the financial cost of patient care. Management strategies are perfectly codified, and photobiomodulation is now recommended internationally with a high level of evidence for the prevention and treatment of oral mucositis and radiodermatitis.
Photobiomodulation (PBM), previously known as low-level laser therapy, has been used for decades in numerous therapeutic indications, based on major scientific knowledge and significant scientific and technological developments Including in fields such as aerospace or military medicine.
CareMin650™ is a photobiomodulation medical device marketed since 2020 and indicated for the treatment of oral mucositis and radiodermatitis.
The aim of the registry is to describe the real-life use of CareMin650™ in France in the preventive and curative treatment of radio and/or chemo-induced oral mucositis and radiodermatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Most patients with cancer or haematological malignancies receiving chemotherapy and presenting with oral mucositis and/or radio- and/or chemo-induced dermatitis will have some form of oral mucositis.
Key inclusion criteria (4 listed)
- Any adult patient over 18 years of age
- Patient treated with the CareMin650™ photobiomodulation device, as a preventive or curative measure for oral mucositis and/or radiodermatitis induced by chemotherapy (in the broadest sense: includes targeted therapies, immunotherapy) and/or radiotherapy, as part of their routine management for any type of cancer or haematological malignancy, whatever the stage and prognosis of the disease
- Information note sent to the patient and record of the patient's or legal representative's (guardian's) non-objection
- Membership of a social security scheme
Key exclusion criteria (6 listed)
- Pregnant women
- Patient with severe cognitive impairment rendering him/her incapable of expressing non-objection to participation in the study.
- If the patient is under guardianship or curatorship: objection from the guardian/curator.
- Patient with a known allergy to polyurethane
- Patient taking part in a clinical study involving medicinal or non-medicinal therapies to treat or prevent oral mucositis or radiodermatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the evolution of the severity of radio- and/or chemo-induced oral mucositis lesions and radiodermatitis during preventive or curative treatment with CareMin650™ between the first and last session.
Time frame: Measured at the first of photobiomodulation and at the last session (Week 12)
* Grading of lesions according to WHO scales for oral mucositis 0 - No lesion 1 - Erythema - moderate pain 2 - Moderate ulceration - solid food 3- Severe ulceration - liquid food 4 - Severe ulceration - no oral feeding * Grading of lesions according to WHO scales for radiodermatitis 0 - No lesion 1. - Mild erythema or dry desquamation 2. - Moderate to vivid erythema - localized moist desquamation in folds - moderate edema 3. - Localized moist desquamation other than in folds - minor bleeding due to light trauma or abrasion 4. - Ulceration or necrosis - spontaneous bleeding - indication for grafting
4 secondary outcomes
Assessment of the satisfaction of professionals using the CareMin650™
Time frame: At last photobiomodulation session Week 12
Assessment of patient satisfaction
Time frame: At last photobiomodulation session week12
Description of the conditions of real-life use of CareMin650™
Time frame: At last session of photobiomodulation week 12
Assessment of the clinical benefit of CareMin650™ in the management of oral mucositis for the patient
Time frame: At last session of photobiomodulation week 12
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 9 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucositis (Ulcerative) and Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, run by Centre Hospitalier de Valenciennes 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the evolution of the severity of radio- and/or chemo-induced oral mucositis lesions and radiodermatitis during preventive or curative treatment with CareMin650™ between the first and last session. (time frame: Measured at the first of photobiomodulation and at the last session (Week 12)). 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 9 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.