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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