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

NeoMedLight

Status: Completed

Conditions: Radiation Dermatitis; Oral Mucositis Due to Radiation

Treatments: Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent); Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03988556

ID-RCB: 2018-A03356-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Exclusion Criteria common to both cohorts:

• 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

  • 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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 4 patient groups

Cohort A1 - Head & neck cancer - Prophylactic intent

Experimental group

Description:

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. .

Treatment:

Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

Cohort A2 - Head & neck cancer - Curative intent

Experimental group

Description:

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.

Treatment:

Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent)

Cohort B1 - Breast cancer - Prophylactic intent

Experimental group

Description:

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.

Treatment:

Device: Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

Cohort B2 - Breast cancer - Curative intent

Experimental group

Description:

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.

Treatment:

Device: Photobiomodulation using CareMin650 at 6 Joules (curative intent)