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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the satisfaction of professionals using the CareMin650™ | Assessment of the satisfaction of CareMin650™ users (nurses, doctors, radio manipulators) :
|
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Inclusion Criteria:
Exclusion Criteria:
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Most patients with cancer or haematological malignancies receiving chemotherapy and presenting with oral mucositis and/or radio- and/or chemo-induced dermatitis will have some form of oral mucositis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Valenciennes | Valenciennes | France | 59300 | France |
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| At last photobiomodulation session Week 12 |
| Assessment of patient satisfaction | Assessment of patient satisfaction following CareMin650™ sessions:
| At last photobiomodulation session week12 |
| Description of the conditions of real-life use of CareMin650™ | Description of the conditions of real-life use of CareMin650™ :
| At last session of photobiomodulation week 12 |
| Assessment of the clinical benefit of CareMin650™ in the management of oral mucositis for the patient | Assessment of the clinical benefit of CareMin650™ in the management of oral mucositis for the patient / QUESTIONNAIRES ABOUT :
| At last session of photobiomodulation week 12 |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D014456 | Ulcer |
| D003872 | Dermatitis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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