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

NCT07054528 | Active Not Recruiting

• 1 other identifier: 2024-03-01
• Study Type: observational
• Target: 33,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Mucositis (Ulcerative); Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy; Oral Mucositis (Ulcerative) Due to Radiation; Dermatitis

Keywords

Oncology; Photobiomodulation; oral mucositis; dermatitis; chemotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  * 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

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

Secondary Outcomes (4)

• Assessment of the satisfaction of professionals using the CareMin650™

  At last photobiomodulation session Week 12

• Assessment of patient satisfaction

  At last photobiomodulation session week12

• 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

  At last session of photobiomodulation week 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, France, 59300, France

Location

MeSH Terms

Conditions

Stomatitis; Ulcer; Dermatitis; Neoplasms

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 8, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): October 30, 2034
• Study Completion (Estimated): October 30, 2034
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)