Active — Not RecruitingNot Applicable

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

France33,000 participantsStarted 2025-06-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

Evaluation of the evolution of the severity of radio- and/or chemo-induced oral mucositis lesions and radiodermatitis during preventive or curative treatment with CareMin650™ between the first and last session.

Timeframe: Measured at the first of photobiomodulation and at the last session (Week 12)

Trial details

NCT IDNCT07054528

SponsorCentre Hospitalier de Valenciennes

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2034-10-30

View on ClinicalTrials.gov More Oral Mucositis (Ulcerative) trials