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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
trial in Oral Mucositis (Ulcerative) in 33,000 participants. Participants enrolled and being followed up; not accepting new ones.
30 October 2034
Quick facts
| Lead sponsor | Centre Hospitalier de Valenciennes |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 33,000 |
| Start date | 20 June 2025 |
| Primary completion | 30 October 2034 |
| Estimated completion | 30 October 2034 |
| Sites | 1 location across France |
Conditions studied
- Oral Mucositis (Ulcerative) — all drugs for Oral Mucositis (Ulcerative) →
- Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy — all drugs for Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy →
- Oral Mucositis (Ulcerative) Due to Radiation — all drugs for Oral Mucositis (Ulcerative) Due to Radiation →
- Dermatitis — all drugs for Dermatitis →
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.
Verify or expand the search:
- PubMed search for NCT07054528
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07054528 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier de Valenciennes
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07054528.
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