Clinical trial NCT06326268: Interest of Light Therapy in Hematology - The PHOTO-TREAT Study
Official title: Validation of the Improvement in the Management of Chemo-induced Mucositis in Hematology Through the Contribution of Photobiomodulation - The PHOTO-TREAT Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia, Myeloid, Acute
Lymphoma
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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

Primary outcomes:
measure: Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM in terms of reduction of the length of hospital stay.
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM in terms of reduction of the number of transfusions.
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM in terms of pain reduction
timeFrame: Up to 12 weeks
measure: Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
affiliation: Institut de cancérologie Strasbourg Europe
name: Anne ZILLIOX, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.