Interest of Light Therapy in Hematology - The PHOTO-TREAT Study
NCT ID: NCT06326268
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-17
2025-09-17
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Photobiomodulation
• Patients: In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant and breastfeeding woman
* Allergy to polyurethanes
18 Years
ALL
No
Sponsors
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Institut de cancérologie Strasbourg Europe
OTHER
Responsible Party
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Principal Investigators
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Anne ZILLIOX, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de cancérologie Strasbourg Europe
Locations
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Institut de cancérologie Strasbourg Europe
Strasbourg, , France
Countries
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Central Contacts
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Manon VOEGELIN
Role: CONTACT
Facility Contacts
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Role: primary
References
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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.
Other Identifiers
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2023-A02133-42
Identifier Type: OTHER
Identifier Source: secondary_id
2023-019
Identifier Type: -
Identifier Source: org_study_id
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