Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Wounds and Injuries

Breast Neoplasms

Head and Neck Neoplasms

Dermatitis

Stomatitis

Mucositis

Radiodermatitis

Skin Diseases

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Radiation Injuries

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.

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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.

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.

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.

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 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 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.

Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

René-Jean Bensadoun, MD

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.

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.

Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis

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

score at visual analogic scale of pain (continuous values from 0 to 10) completed by patients

Assessment of patients analgesic consumption for the pain induced by the oral mucositis and/or radiation dermatitis lesion(s)

Assessment of oral lesion(s) consequences on food intake

SF-12 questionnaire score (12 questions, 2 subscores: mental quality of life score and physical quality of life score) assessed by patients

Questionnaire of satisfaction (developed by the sponsor; 9 questions on pain, comfort, duration of sessions, ability to hold the device alone and global satisfaction) completed by patients

questionnaire of convenience of the device and satisfaction (developed by the sponsor; 12 questions on use, experience with the device, technical settings, duration of sessions and global recommendations) completed by health professionals

ECOG (Eastern Cooperative Oncology Group) performance status (score from 0 to 5) assessed by the investigator

Number of therapeutic sessions with the device

Frequency of therapeutic sessions with the device

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.

Severity grade according to CTCAE V3 (0 (absence) to 5 (death))

Time until resolution (defined as lesions that do not require further treatment).

Spots Global Cancer Trial Database for oral mucositis due to radiation