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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• 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. — Measured at the first of photobiomodulation and at the last session (Week 12)
  * Grading of lesions according to WHO scales for oral mucositis 0 - No lesion 1 - Erythema - moderate pain 2 - Moderate ulceration - solid food 3- Severe ulceration - liquid food 4 - Severe ulceration - no oral feeding * Grading of lesions according to WHO scales for radiodermatitis 0 - No lesion 1. \- Mild erythema or dry desquamation 2. \- Moderate to vivid erythema - localized moist desquamation in folds - moderate edema 3. \- Localized moist desquamation other than in folds - minor bleeding due to light trauma or abrasion 4. \- Ulceration or necrosis - spontaneous bleeding - indication for grafting

Trial sites (1)

More Centre Hospitalier de Valenciennes trials in France

Other trials for the same condition