Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis

NCT ID: NCT07054528

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 33000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2034-10-30

Brief Summary

Most patients with cancer or haematological malignancies who receive chemotherapy - broadly defined to include targeted therapies and immunotherapy - and/or external beam radiotherapy may experience serious and disabling adverse events related to these treatments.

Mucositis and radiodermatitis are a frequent and disabling complication of cancer and haematological malignancy treatments: chemotherapy (in the broadest sense: includes immunotherapy, targeted therapies) and/or radiotherapy, having a considerable impact on patients' quality of life.

Mucositis is linked to lesions that occur in epithelial and connective tissues in response to a complex cascade of biological events involving the cellular elements of the mucosa.

All these consequences make for an inadequate care pathway (hospitalisations and urgent care, complications, decompensations of comorbidities) and considerably increase the financial cost of patient care. Management strategies are perfectly codified, and photobiomodulation is now recommended internationally with a high level of evidence for the prevention and treatment of oral mucositis and radiodermatitis.

Photobiomodulation (PBM), previously known as low-level laser therapy, has been used for decades in numerous therapeutic indications, based on major scientific knowledge and significant scientific and technological developments Including in fields such as aerospace or military medicine.

CareMin650™ is a photobiomodulation medical device marketed since 2020 and indicated for the treatment of oral mucositis and radiodermatitis.

The aim of the registry is to describe the real-life use of CareMin650™ in France in the preventive and curative treatment of radio and/or chemo-induced oral mucositis and radiodermatitis.

Conditions

Oral Mucositis (Ulcerative); Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy; Oral Mucositis (Ulcerative) Due to Radiation; Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Any adult patient over 18 years of age
• Patient treated with the CareMin650™ photobiomodulation device, as a preventive or curative measure for oral mucositis and/or radiodermatitis induced by chemotherapy (in the broadest sense: includes targeted therapies, immunotherapy) and/or radiotherapy, as part of their routine management for any type of cancer or haematological malignancy, whatever the stage and prognosis of the disease
• Information note sent to the patient and record of the patient's or legal representative's (guardian's) non-objection
• Membership of a social security scheme

Exclusion Criteria

• Pregnant women
• Patient with severe cognitive impairment rendering him/her incapable of expressing non-objection to participation in the study.
• If the patient is under guardianship or curatorship: objection from the guardian/curator.
• Patient with a known allergy to polyurethane
• Patient taking part in a clinical study involving medicinal or non-medicinal therapies to treat or prevent oral mucositis or radiodermatitis.
• Patients physically unable to apply Ora-Pad and Derma-Pad devices (e.g. limited mouth opening).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier de Valenciennes

Valenciennes, France, France

Countries

France

Other Identifiers

2024-03-01

Identifier Type: -

Identifier Source: org_study_id