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

NCT03988556 | Completed

• 1 other identifier: ID-RCB: 2018-A03356-49
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

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.

Conditions

Oral Mucositis Due to Radiation; Radiation Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• Rate of discontinuation due to AEs

  Rate of discontinuation due to AEs.

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

Secondary Outcomes (10)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (12)

• 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)

• 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)

• 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)

Study Arms (4)

Cohort A1 - Head & neck cancer - Prophylactic intent

EXPERIMENTAL

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. .

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

Cohort A2 - Head & neck cancer - Curative intent

EXPERIMENTAL

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.

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

Cohort B1 - Breast cancer - Prophylactic intent

EXPERIMENTAL

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.

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

Cohort B2 - Breast cancer - Curative intent

EXPERIMENTAL

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.

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

Interventions

Photobiomodulation using CareMin650 at 6 Joules (curative intent) DEVICE

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.

Cohort A2 - Head & neck cancer - Curative intent; Cohort B2 - Breast cancer - Curative intent

Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent) DEVICE

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.

Cohort A1 - Head & neck cancer - Prophylactic intent; Cohort B1 - Breast cancer - Prophylactic intent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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
• Active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding
• Hb \< 8g/dL; neutrophils \< 1000 mm3; platelets \< 50 000/mm3
• Previous irradiation to the same breast

Sponsors & Collaborators

• NeoMedLight: lead
• Qualissima: collaborator

Study Sites (5)

Institut de radiothérapie et radiochirurgie Hartmann

Levallois-Perret, 92309, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre de Haute Energie

Nice, 06000, France

Location

Institut Curie

Paris, 75248, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Related Links

• Website of Neomedlight

MeSH Terms

Conditions

Radiodermatitis; Stomatitis; Head and Neck Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• René-Jean Bensadoun, MD

  Centre de Haute Energie - Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: July 4, 2019
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)