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

NCT ID: NCT06326268

Last Updated: 2024-04-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2025-09-17

Brief Summary

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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

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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).

Conditions

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Leukemia, Myeloid, Acute Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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;

Group Type OTHER

Phototherapy system CareMin650TM

Intervention Type DEVICE

* 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire VIT

Role: CONTACT

(0)3 68 33 95 23 ext. +33

Manon VOEGELIN

Role: CONTACT

Facility Contacts

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Role: primary

(0)3 68 33 95 23 ext. +33

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.

Reference Type BACKGROUND
PMID: 38439757 (View on PubMed)

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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