Oral Mucositis Due to RadiationSafePBMNCT03988556
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
A study testing Photobiomodulation using CareMin650 at 6 Joules (curative intent) and Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent) in people with Oral Mucositis Due to Radiation and Radiation Dermatitis, run by NeoMedLight at 5 sites in France.
Trial summary
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis Due to Radiation, Radiation Dermatitis
- What is being tested?
- Photobiomodulation using CareMin650 at 6 Joules (curative intent) and Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Jul 2019to 17 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients (age ≥18 years) accepting to participate in the study and having signed the written informed consent form prior to any protocol-specific procedures.
- Having an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- Having a life expectancy greater than 3 months according to the investigator medical judgement.
- Having the ability to understand and sign the written informed consent form and willing to comply with protocol requirements.
- Specific criteria for inclusion in head and neck cancer cohort (cohort A):
- Patient with histologically proven squamous cell carcinoma of oropharynx, nasopharynx, hypopharynx, larynx or oral cavity with or without prior surgical resection
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- Patient with dental examination prior to chemo-radiotherapy and any required dental treatment performed
- In cohort A1 (patient with no oral mucosa or skin lesion, starting radiotherapy), patient scheduled to receive intensity modulated radiation therapy on at least 50% of the oral mucosa at a total dose of at least 40 Gy, alone or associated with chemotherapy or targeted therapies.
- In cohort A2, (on-going radiotherapy), presence of oral mucositis and/or radiation dermatitis grade 1, 2 or 3.
- Specific criteria for inclusion in breast cancer cohort (cohort B)
- Patient with histologically proven breast cancer
- After breast-conserving surgery, or total mastectomy if the patient is at high risk of radiodermatitis based on the investigator's judgement.
- In cohort B1, (patient with no skin lesion starting radiotherapy) patient scheduled to receive radiation therapy.
- In cohort B2 (on-going radiotherapy) presence of radiation dermatitis grade 1, 2 or 3.
Who cannot join
- Any condition that may interfere with adherence to treatment according to the investigator's judgment
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Patient with a known polyurethane allergy
- Females patients who are pregnant or breastfeeding
- Female patients who do not fall into 1 of the following categories:
- Post-menopausal
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- Surgically sterile
- Using one of the following birth control methods throughout the duration of the study:
- Intrauterine device (> 14 days)
- Barrier method (condom or diaphragm) with spermicide (> 14 days)
- Hormonal contraception (same dose and same formulation for at least 6 months)
- Patient participating in another clinical trial involving drugs or non-drug therapies aiming to treat or prevent lesions induced by radiotherapy
- Specific criteria for non inclusion in head and neck cancer cohort (coh ort A):
- Active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding
- Hb < 8g/dL; neutrophils < 1000 mm3; platelets < 50 000/mm3
- Specific criteria for non inclusion in breast cancer cohort (cohort B):
- Previous irradiation to the same breast
- Any pre-existing skin disorders located on the chest
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Institut de radiothérapie et radiochirurgie Hartmann
Levallois-Perret, 92309
Centre Oscar Lambret
Lille, 59000
Centre de Haute Energie
Nice, 06000
Institut Curie
Paris, 75248
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Official title: Feasibility and Safety of CareMin650 in Cancer Patients at High Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis Due to the Administration of Radiotherapy: A Prospective Non-comparative Study
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
Read the detailed description
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
This is a prospective non-comparative study. Two cohorts of patients will be included, based on the tumour location. Each cohort will be divided into two subgroups according to whether the treatment is for curative or preventive purposes.
- Patients with head \& neck cancer (cohort A), either starting radiotherapy with or without chemotherapy with or without targeted therapy (no lesions, prophylactic intent, cohort A1) or having started treatment and presenting with grade 1 to 3 lesions of oral mucositis and/or radiation dermatitis (curative intent, cohort A2).
- Patients with breast cancer requiring radiation therapy (cohort B), either starting radiation therapy (i.e. no lesions, prophylactic intent, cohort B1) or having started treatment and presenting with grade 1 to 3 lesions of radiation dermatitis (curative intent, cohort B2) it is planned to select a maximum number of 72 patients (36 in each cohort)
Consecutive patients will be included in each of the four predefined subgroups, until the target number of patients in each subgroup has been reached.
The photobiomodulation treatment will be initiated at inclusion and will be continued for the duration of radiotherapy (6 to 8 weeks maximum).
The maximum total participation in the study is anticipated to be approximately ten weeks for each patient.
- Being tested
- Photobiomodulation using CareMin650 at 6 Joules (curative intent), Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Keywords
- Photobiomodulation, Oral Mucositis, Radiation Dermatitis, Radiotherapy, Head and neck cancer, Breast cancer
- Medical subject headings
- Radiodermatitis, Stomatitis, Head and Neck Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation using CareMin650 at 6 Joules (curative intent)Device
CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.
For curative treatment, the dose to be delivered has been set at 6J/cm2. If the lesions of patients included in a curative cohort are resolved before the end of the radiotherapy period, the treatment will be applied with a preventive aim and the dose will decrease from 6 to 3J/cm2.
Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)Device
CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.
For prophylactic treatment, the dose to be delivered has been set at 3J/cm2. If oral mucositis or radiodermatitis occurs in a patient included in a prophylactic cohort, the lesions will be treated with a curative intent and the dose will increase from 3 to 6J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 - Head & neck cancer - Prophylactic intent | Experimental | Patients with head \& neck cancer starting radiotherapy +/- chemotherapy +/- targeted therapy (no lesions, prophylactic intent).
Treatment with CareMin650 will start on the first day of radiotherapy and will be administered during the whole radiotherapy period (6 to 8 weeks maximum), ideally 5 days/week, at least 3 days/week, before or after the radiotherapy session.
The device will be used on irradiated areas presenting a risk of radiotherapy-related complications. The prophylactic treatment will aim at preventing both oral mucositis and radiodermatitis.
. Receives: Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent) |
| Cohort A2 - Head & neck cancer - Curative intent | Experimental | Patients with head \& neck cancer having started radiation therapy and presenting with grade 1 to 3 lesions of oral mucositis and/or radiation dermatitis (curative intent).
Treatment with CareMin650 will start as soon as the lesion is diagnosed and will be administered at each radiotherapy session, during the whole radiotherapy period (6 to 8 weeks maximum).
The device will be used on each lesion. All existing lesions will be treated whether they are oral mucositis or radiodermatitis lesions. Receives: Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent) |
| Cohort B1 - Breast cancer - Prophylactic intent | Experimental | Patients with breast cancer starting radiation therapy (i.e. no lesions, prophylactic intent).
Treatment with CareMin650 will start on the first day of radiotherapy and will be administered during the whole radiotherapy period (6 to 8 weeks maximum), ideally 5 days/week, at least 3 days/week, before or after the radiotherapy session.
The device will be used on irradiated areas presenting a risk of radiotherapy-related complications. The prophylactic treatment will aim at preventing radiodermatitis. Receives: Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent) |
| Cohort B2 - Breast cancer - Curative intent | Experimental | Patients with breast cancer having started radiation therapy and presenting with grade 1 to 3 lesions of radiation dermatitis (curative intent).
Treatment with CareMin650 will start as soon as the lesion is diagnosed and will be administered at each radiotherapy session, during the whole radiotherapy period (6 to 8 weeks maximum).
The device will be used on each lesion. All existing lesions will be treated. Receives: Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of adverse events
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: Continuous (from screening visit to Follow-up visit (10 weeks maximum) + 30 days )
Rate of discontinuation due to AEs
Rate of discontinuation due to AEs.
Measured: Continuous on 6 to 8 weeks maximum (Inclusion visit to End of radiotherapy visit)
Secondary outcomes (10)
Skin lesions assessment - time of lesion occurrence
time of lesion occurrence
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - size of lesions
size of lesions (centimeters square)
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - location
location
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - Grade
Severity grade according to CTCAE V3 (0 (absence) to 5 (death))
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - Time until resolution
Time until resolution (defined as lesions that do not require further treatment).
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - time of lesion occurrence
time of lesion occurrence
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - size of lesions
size of lesions (centimeters square)
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - location
Location
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - Grade
Severity grade according to CTCAE V3 (0 (absence) to 5 (death))
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - Time until resolution
Time until resolution (defined as lesions that do not require further treatment).
Measured: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start4 Jul 2019
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis Due to RadiationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoMedLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qualissima
- Responsible party
- Sponsor
- Investigators
- René-Jean Bensadoun, MD, Principal investigator, Centre de Haute Energie - Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988556
- Sponsor's protocol ID
- ID-RCB: 2018-A03356-49
- Acronym
- SafePBM
- Status last verified
- Apr 2021
- First submitted
- 12 Jun 2019
- Last updated
- 30 Apr 2021
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of CareMin650 in Cancer Patients at High Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis Due to the Administration of Radiotherapy: A Prospective Non-comparative Study
- ClinicalTrials.gov ID
- NCT03988556
- Acronym / sponsor ID
- SafePBM / ID-RCB: 2018-A03356-49
- Keywords
- Photobiomodulation, Oral Mucositis, Radiation Dermatitis, Radiotherapy, Head and neck cancer, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NeoMedLightIndustry (pharma, biotech, devices)
- Collaborators
- Qualissima
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 17 Jun 2019 (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.
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
Detailed description
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
This is a prospective non-comparative study. Two cohorts of patients will be included, based on the tumour location. Each cohort will be divided into two subgroups according to whether the treatment is for curative or preventive purposes.
- Patients with head \& neck cancer (cohort A), either starting radiotherapy with or without chemotherapy with or without targeted therapy (no lesions, prophylactic intent, cohort A1) or having started treatment and presenting with grade 1 to 3 lesions of oral mucositis and/or radiation dermatitis (curative intent, cohort A2).
- Patients with breast cancer requiring radiation therapy (cohort B), either starting radiation therapy (i.e. no lesions, prophylactic intent, cohort B1) or having started treatment and presenting with grade 1 to 3 lesions of radiation dermatitis (curative intent, cohort B2) it is planned to select a maximum number of 72 patients (36 in each cohort)
Consecutive patients will be included in each of the four predefined subgroups, until the target number of patients in each subgroup has been reached.
The photobiomodulation treatment will be initiated at inclusion and will be continued for the duration of radiotherapy (6 to 8 weeks maximum).
The maximum total participation in the study is anticipated to be approximately ten weeks for each patient.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 - Head & neck cancer - Prophylactic intent | Experimental | Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)Patients with head \& neck cancer starting radiotherapy +/- chemotherapy +/- targeted therapy (no lesions, prophylactic intent). Treatment with CareMin650 will start on the first day of radiotherapy and will be administered during the whole radiotherapy period (6 to 8 weeks maximum), ideally 5 days/week, at least 3 days/week, before or after the radiotherapy session. The device will be used on irradiated areas presenting a risk of radiotherapy-related complications. The prophylactic treatment will aim at preventing both oral mucositis and radiodermatitis. . |
| Cohort A2 - Head & neck cancer - Curative intent | Experimental | Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent)Patients with head \& neck cancer having started radiation therapy and presenting with grade 1 to 3 lesions of oral mucositis and/or radiation dermatitis (curative intent). Treatment with CareMin650 will start as soon as the lesion is diagnosed and will be administered at each radiotherapy session, during the whole radiotherapy period (6 to 8 weeks maximum). The device will be used on each lesion. All existing lesions will be treated whether they are oral mucositis or radiodermatitis lesions. |
| Cohort B1 - Breast cancer - Prophylactic intent | Experimental | Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)Patients with breast cancer starting radiation therapy (i.e. no lesions, prophylactic intent). Treatment with CareMin650 will start on the first day of radiotherapy and will be administered during the whole radiotherapy period (6 to 8 weeks maximum), ideally 5 days/week, at least 3 days/week, before or after the radiotherapy session. The device will be used on irradiated areas presenting a risk of radiotherapy-related complications. The prophylactic treatment will aim at preventing radiodermatitis. |
| Cohort B2 - Breast cancer - Curative intent | Experimental | Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent)Patients with breast cancer having started radiation therapy and presenting with grade 1 to 3 lesions of radiation dermatitis (curative intent). Treatment with CareMin650 will start as soon as the lesion is diagnosed and will be administered at each radiotherapy session, during the whole radiotherapy period (6 to 8 weeks maximum). The device will be used on each lesion. All existing lesions will be treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients (age ≥18 years) accepting to participate in the study and having signed the written informed consent form prior to any protocol-specific procedures.
- Having an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- Having a life expectancy greater than 3 months according to the investigator medical judgement.
- Having the ability to understand and sign the written informed consent form and willing to comply with protocol requirements.
- Patient with histologically proven squamous cell carcinoma of oropharynx, nasopharynx, hypopharynx, larynx or oral cavity with or without prior surgical resection
Key exclusion criteria (18 listed)
- Any condition that may interfere with adherence to treatment according to the investigator's judgment
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
- Patient with a known polyurethane allergy
- Females patients who are pregnant or breastfeeding
- Female patients who do not fall into 1 of the following categories:
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 |
|---|---|---|
| Photobiomodulation using CareMin650 at 6 Joules (curative intent)CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa. For curative treatment, the dose to be delivered has been set at 6J/cm2. If the lesions of patients included in a curative cohort are resolved before the end of the radiotherapy period, the treatment will be applied with a preventive aim and the dose will decrease from 6 to 3J/cm2. | Device | Cohort A2 - Head & neck cancer - Curative intent, Cohort B2 - Breast cancer - Curative intent |
| Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa. For prophylactic treatment, the dose to be delivered has been set at 3J/cm2. If oral mucositis or radiodermatitis occurs in a patient included in a prophylactic cohort, the lesions will be treated with a curative intent and the dose will increase from 3 to 6J/cm2. | Device | Cohort A1 - Head & neck cancer - Prophylactic intent, Cohort B1 - Breast cancer - Prophylactic intent |
Primary outcome
Occurence of adverse events
Time frame: Continuous (from screening visit to Follow-up visit (10 weeks maximum) + 30 days )
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Rate of discontinuation due to AEs
Time frame: Continuous on 6 to 8 weeks maximum (Inclusion visit to End of radiotherapy visit)
Rate of discontinuation due to AEs.
10 secondary outcomes
Skin lesions assessment - time of lesion occurrence
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - size of lesions
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - location
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - Grade
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Skin lesions assessment - Time until resolution
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - time of lesion occurrence
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - size of lesions
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - location
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - Grade
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Oral mucosa lesions assessment - Time until resolution
Time frame: Inclusion visit, before each therapeutic session with the device (6 to 8 weeks maximum), end of radiotherapy visit (after 6 to 8 weeks maximum), Follow-up visit (7 to 13 days after last exposition)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Website of NeomedlightLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
René-Jean Bensadoun, MD principal investigator
Centre de Haute Energie - Nice
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation using CareMin650 at 6 Joules (curative intent) and Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent) in people with Oral Mucositis Due to Radiation and Radiation Dermatitis, run by NeoMedLight at 5 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 14 inclusion and 18 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: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurence of adverse events (time frame: Continuous (from screening visit to Follow-up visit (10 weeks maximum) + 30 days )). The study lists 2 primary outcomes in all. 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 30 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.