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NCT07054528: NéoPBM

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

Active, enrolled Last updated 9 February 2026
What this trial tests

trial in Oral Mucositis (Ulcerative) in 33,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
20 June 2025
Primary endpoint
30 October 2034
30 October 2034

Quick facts

Lead sponsorCentre Hospitalier de Valenciennes
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment33,000
Start date20 June 2025
Primary completion30 October 2034
Estimated completion30 October 2034
Sites1 location across France

Conditions studied

Sponsor

Centre Hospitalier de Valenciennes

Who can join

18 and older, any sex, with Oral Mucositis (Ulcerative) or Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Centre Hospitalier de Valenciennes trials

Trials by the same sponsor.

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Data sources for this page

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