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

Primary Purpose

Oral Mucositis Due to Radiation, Radiation Dermatitis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Photobiomodulation using CareMin650 at 6 Joules (curative intent)

Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

About this trial

This is an interventional other trial for Oral Mucositis Due to Radiation focused on measuring Photobiomodulation, Oral Mucositis, Radiation Dermatitis, Radiotherapy, Head and neck cancer, Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institut de radiothérapie et radiochirurgie Hartmann
Centre Oscar Lambret
Centre de Haute Energie
Institut Curie
Institut de Cancérologie Lucien Neuwirth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort A1 - Head & neck cancer - Prophylactic intent

Cohort A2 - Head & neck cancer - Curative intent

Cohort B1 - Breast cancer - Prophylactic intent

Cohort B2 - Breast cancer - Curative intent

Arm 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. .

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.

Outcomes

Primary Outcome Measures

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.

Rate of discontinuation due to AEs

Rate of discontinuation due to AEs.

Secondary Outcome Measures

Skin lesions assessment - time of lesion occurrence

time of lesion occurrence

Skin lesions assessment - size of lesions

size of lesions (centimeters square)

Skin lesions assessment - location

location

Skin lesions assessment - Grade

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

Skin lesions assessment - Time until resolution

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

Oral mucosa lesions assessment - time of lesion occurrence

time of lesion occurrence

Oral mucosa lesions assessment - size of lesions

size of lesions (centimeters square)

Oral mucosa lesions assessment - location

Location

Oral mucosa lesions assessment - Grade

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

Oral mucosa lesions assessment - Time until resolution

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

Full Information

NCT ID

NCT03988556

First Posted

June 12, 2019

Last Updated

April 29, 2021

Sponsor

NeoMedLight

Collaborators

Qualissima

1. Study Identification

Unique Protocol Identification Number

NCT03988556

Brief Title

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

Acronym

SafePBM

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 4, 2019 (Actual)

Primary Completion Date

December 17, 2020 (Actual)

Study Completion Date

December 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeoMedLight

Collaborators

Qualissima

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis Due to Radiation, Radiation Dermatitis

Keywords

Photobiomodulation, Oral Mucositis, Radiation Dermatitis, Radiotherapy, Head and neck cancer, Breast cancer

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A1 - Head & neck cancer - Prophylactic intent

Arm Type

Experimental

Arm Description

Arm Title

Cohort A2 - Head & neck cancer - Curative intent

Arm Type

Experimental

Arm Description

Arm Title

Cohort B1 - Breast cancer - Prophylactic intent

Arm Type

Experimental

Arm Description

Arm Title

Cohort B2 - Breast cancer - Curative intent

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Photobiomodulation using CareMin650 at 6 Joules (curative intent)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Occurence of adverse events

Description

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.

Time Frame

Continuous (from screening visit to Follow-up visit (10 weeks maximum) + 30 days )

Title

Rate of discontinuation due to AEs

Description

Rate of discontinuation due to AEs.

Time Frame

Continuous on 6 to 8 weeks maximum (Inclusion visit to End of radiotherapy visit)

Secondary Outcome Measure Information:

Title

Skin lesions assessment - time of lesion occurrence

Description

time of lesion occurrence

Time Frame