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

Not Applicable

Recruiting

• Conditions: Lymphoma; Leukemia, Myeloid, Acute

• Registration Number: NCT06326268
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief 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).

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-22
• Status Verified: 2024-04
• Study Start: 2024-04-17
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-09-17
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patient;
• Patients:

In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;

• Signature of informed consent;
• Patient registered with social security.

Exclusion Criteria

• Patient under guardianship or curatorship
• Pregnant and breastfeeding woman
• Allergy to polyurethanes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis	Up to 12 weeks	Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Evaluate the impact of PBM in terms of reduction of the number of transfusions.	Up to 12 weeks	Number of transfusions during hospitalization
Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.	Up to 12 weeks	Consumption of level III analgesics during aplasia after chemotherapy.
Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.	Up to 12 weeks	Consumption of systemic anti-infectives during aplasia after induction and conditioning chemotherapy.
Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.	Up to 12 weeks	Duration of artificial nutrition during aplasia
Evaluate the impact of PBM in terms of reduction of the length of hospital stay.	Up to 12 weeks	Length of hospitalization
Evaluate the impact of PBM in terms of pain reduction	Up to 12 weeks	Assessment using a visual analogue scale (VAS, graded from 0 to 10). Measurement before and after each PBM session.
Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay	Up to 12 weeks	Evaluation of patient satisfaction with the hospital stay - questions on pain management from the Picker Patient Experience Questionnaire

Trial Locations

Locations (1)

Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France