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

Lymphoma Clinical Trial

— PHOTO-TREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326268
• Other study ID #: 2023-019
• Secondary ID: 2023-A02133-42
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: September 17, 2025

Study information

• Verified date: April 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Claire VIT
• Phone: (0)3 68 33 95 23
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 17, 2025
• Est. primary completion date: September 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

References & Publications (1)

Buclin CP, Uribe A, Daverio JE, Iseli A, Siebert JN, Haller G, Cullati S, Courvoisier DS. Validation of French versions of the 15-item picker patient experience questionnaire for adults, teenagers, and children inpatients. Front Public Health. 2024 Feb 19;12:1297769. doi: 10.3389/fpubh.2024.1297769. eCollection 2024. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis	Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria	Up to 12 weeks
Secondary	Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.	Consumption of level III analgesics during aplasia after chemotherapy.	Up to 12 weeks
Secondary	Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.	Consumption of systemic anti-infectives during aplasia after induction and conditioning chemotherapy.	Up to 12 weeks
Secondary	Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.	Duration of artificial nutrition during aplasia	Up to 12 weeks
Secondary	Evaluate the impact of PBM in terms of reduction of the length of hospital stay.	Length of hospitalization	Up to 12 weeks
Secondary	Evaluate the impact of PBM in terms of reduction of the number of transfusions.	Number of transfusions during hospitalization	Up to 12 weeks
Secondary	Evaluate the impact of PBM in terms of pain reduction	Assessment using a visual analogue scale (VAS, graded from 0 to 10). Measurement before and after each PBM session.	Up to 12 weeks
Secondary	Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay	Evaluation of patient satisfaction with the hospital stay - questions on pain management from the Picker Patient Experience Questionnaire	Up to 12 weeks