Oral Mucositis Due to Radiation, Radiation Dermatitis
Conditions
Keywords
Photobiomodulation, Oral Mucositis, Radiation Dermatitis, Radiotherapy, Head and neck cancer, Breast cancer
Brief 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 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.
Interventions
DEVICEPhotobiomodulation 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.
DEVICEPhotobiomodulation 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.
Sponsors
Qualissima
NeoMedLight
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria common to both cohorts: * 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of adverse events | 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 | Continuous on 6 to 8 weeks maximum (Inclusion visit to End of radiotherapy visit) | Rate of discontinuation due to AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin lesions assessment - time of lesion occurrence | 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) | time of lesion occurrence |
| Skin lesions assessment - size of lesions | 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) | size of lesions (centimeters square) |
| Skin lesions assessment - location | 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) | location |
| Skin lesions assessment - Grade | 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) | Severity grade according to CTCAE V3 (0 (absence) to 5 (death)) |
| Skin lesions assessment - Time until resolution | 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) | Time until resolution (defined as lesions that do not require further treatment). |
| Oral mucosa lesions assessment - time of lesion occurrence | 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) | time of lesion occurrence |
| Oral mucosa lesions assessment - size of lesions | 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) | size of lesions (centimeters square) |
| Oral mucosa lesions assessment - location | 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) | Location |
| Oral mucosa lesions assessment - Grade | 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) | Severity grade according to CTCAE V3 (0 (absence) to 5 (death)) |
| Oral mucosa lesions assessment - Time until resolution | 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) | Time until resolution (defined as lesions that do not require further treatment). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Score at visual analogic scale of pain | Inclusion visit, first therapeutic session with the device of each radiotherapy week (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) | score at visual analogic scale of pain (continuous values from 0 to 10) completed by patients |
| Analgesic consumption | Inclusion visit, first therapeutic session with the device of each radiotherapy week (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) | Assessment of patients analgesic consumption for the pain induced by the oral mucositis and/or radiation dermatitis lesion(s) |
| Xerostomia assessment | First therapeutic session with the device of each radiotherapy week (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) | Assessment of xerostomia grade (0 to 3) |
| Food intake | Inclusion visit, first therapeutic session with the device of each radiotherapy week (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) | Assessment of oral lesion(s) consequences on food intake |
| Patients quality of life | 2 times: Inclusion visit, end of radiotherapy visit (after 6 to 8 weeks maximum) | SF-12 questionnaire score (12 questions, 2 subscores: mental quality of life score and physical quality of life score) assessed by patients |
| Patients satisfaction | 1 time: end of radiotherapy visit (after 6 to 8 weeks maximum) | 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 |
| Convenience of the device and satisfaction of the operator | 1 time: end of radiotherapy visit (after 6 to 8 weeks maximum) | 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 Scale of Performance Status | 2 times: Inclusion visit, end of radiotherapy visit (after 6 to 8 weeks maximum) | ECOG (Eastern Cooperative Oncology Group) performance status (score from 0 to 5) assessed by the investigator |
| Use of the device - Number of sessions | throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum) | Number of therapeutic sessions with the device |
| Use of the device - Frequency of use | throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum) | Frequency of therapeutic sessions with the device |
| Use of the device - Cumulative duration of use | throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum) | Cumulative duration of procedures |
| Use of the device - Cumulative dose | throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum) | Cumulative dose delivered |
Countries
France
Outcome results
None listed