NCT06326268

Interest of Light Therapy in Hematology - The PHOTO-TREAT Study

Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients. The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology).

Detailed description

During this research, the investigators aim at validating the efficacy and impact of photo-biomodulation in the management of chemo-induced mucositis in hematology department of Strasbourg Cancer Institute (ICANS).

Conditions

• Leukemia, Myeloid, Acute
• Lymphoma

Interventions

Type	Name	Description
DEVICE	Phototherapy system CareMin650TM	* As part of preventive treatment: Photobiomodulation sessions will be carried out at a dose of 3 joules for 1 minute 51 seconds, 3 times a week (for a maximum duration of 4 to 6 weeks). * As part of curative treatment (i.e. for patients developing mucositis, from grade I): photobiomodulation will be carried out at a curative dose of 6 joules daily (for a maximum duration of 4 to 6 weeks ) for 3 minutes 34 seconds.

Timeline

• Start date: 2024-04-17
• Primary completion: 2025-09-17
• Completion: 2025-09-17
• First posted: 2024-03-22
• Last updated: 2024-04-22

Locations

1 site across 1 country: France