Clinical trial NCT03988556: Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
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
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis Due to Radiation
Radiation Dermatitis
Keywords: Photobiomodulation
Oral Mucositis
Radiation Dermatitis
Radiotherapy
Head and neck cancer
Breast cancer
Lead sponsor: NeoMedLight
Sponsor class: INDUSTRY
Collaborators: name: Qualissima
First posted: 2019-06-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurence of adverse events
timeFrame: Continuous (from screening visit to Follow-up visit (10 weeks maximum) + 30 days )
measure: Rate of discontinuation due to AEs
timeFrame: Continuous on 6 to 8 weeks maximum (Inclusion visit to End of radiotherapy visit)
Secondary outcomes:
measure: Skin lesions assessment - time of lesion occurrence
timeFrame: 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)
measure: Skin lesions assessment - size of lesions
timeFrame: 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)
measure: Skin lesions assessment - location
timeFrame: 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)
measure: Skin lesions assessment - Grade
timeFrame: 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)
measure: Skin lesions assessment - Time until resolution
timeFrame: 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)
measure: Oral mucosa lesions assessment - time of lesion occurrence
timeFrame: 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)
measure: Oral mucosa lesions assessment - size of lesions
timeFrame: 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)
measure: Oral mucosa lesions assessment - location
timeFrame: 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)
measure: Oral mucosa lesions assessment - Grade
timeFrame: 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)
measure: Oral mucosa lesions assessment - Time until resolution
timeFrame: 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)
Other outcomes:
measure: Score at visual analogic scale of pain
timeFrame: 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)
measure: Analgesic consumption
timeFrame: 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)
measure: Xerostomia assessment
timeFrame: 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)
measure: Food intake
timeFrame: 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)
measure: Patients quality of life
timeFrame: 2 times: Inclusion visit, end of radiotherapy visit (after 6 to 8 weeks maximum)
measure: Patients satisfaction
timeFrame: 1 time: end of radiotherapy visit (after 6 to 8 weeks maximum)
measure: Convenience of the device and satisfaction of the operator
timeFrame: 1 time: end of radiotherapy visit (after 6 to 8 weeks maximum)
measure: ECOG Scale of Performance Status
timeFrame: 2 times: Inclusion visit, end of radiotherapy visit (after 6 to 8 weeks maximum)
measure: Use of the device - Number of sessions
timeFrame: throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum)
measure: Use of the device - Frequency of use
timeFrame: throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum)
measure: Use of the device - Cumulative duration of use
timeFrame: throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum)
measure: Use of the device - Cumulative dose
timeFrame: throughout the entire treatment period with the device (Day 1 until 6 to 8 weeks maximum)
Locations:
city: Levallois-Perret
country: France
facility: Institut de radiothérapie et radiochirurgie Hartmann
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nice
country: France
facility: Centre de Haute Energie
city: Paris
country: France
facility: Institut Curie
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Centre de Haute Energie - Nice
name: René-Jean Bensadoun, MD
role: PRINCIPAL_INVESTIGATOR
References: