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Trial Title: Interest of Light Therapy in Hematology - The PHOTO-TREAT Study

NCT ID: NCT06326268

Condition: Leukemia, Myeloid, Acute
Lymphoma

Conditions: Official terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Phototherapy system CareMin650TM
Description: - 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.
Arm group label: Photobiomodulation

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).

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut de cancérologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Status: Recruiting

Contact:

Phone: (0)3 68 33 95 23

Phone ext: +33
Email: promotion-rc@icans.eu

Investigator:
Last name: Anne ZILLIOX, MD
Email: Principal Investigator

Start date: April 17, 2024

Completion date: September 17, 2025

Lead sponsor:
Agency: Institut de cancérologie Strasbourg Europe
Agency class: Other

Source: Institut de cancérologie Strasbourg Europe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06326268

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