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

April 19, 2024 updated by: Institut de cancérologie Strasbourg Europe

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Manon VOEGELIN

Study Locations

  • France
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe
        • Contact:
        • Principal Investigator:
          • Anne ZILLIOX, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Photobiomodulation
• Patients: In induction of acute myeloblastic leukemia OR Allografts in first remission with myeloablative conditioning OR Autografts in the context of aggressive lymphoma;
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
Time Frame: Up to 12 weeks
Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria
Up to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Investigators

  • Principal Investigator: Anne ZILLIOX, MD, Institut de cancérologie Strasbourg Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2024

Primary Completion (Estimated)

September 17, 2025

Study Completion (Estimated)

September 17, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-019
  • 2023-A02133-42 (Other Identifier: ID-RCB Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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