NCT06326268

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.4 years

First QC Date

March 11, 2024

Last Update Submit

April 19, 2024

Conditions

Leukemia, Myeloid, AcuteLymphoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis

    Rate of occurrence of mucositis, graded according to NCI-CTCAE V5.0 criteria

    Up to 12 weeks

Secondary Outcomes (7)

  • Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption.

    Up to 12 weeks

  • Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction.

    Up to 12 weeks

  • Evaluate the impact of PBM in terms of reduction of the use of artificial feeding.

    Up to 12 weeks

  • Evaluate the impact of PBM in terms of reduction of the length of hospital stay.

    Up to 12 weeks

  • Evaluate the impact of PBM in terms of reduction of the number of transfusions.

    Up to 12 weeks

  • +2 more secondary outcomes

Study Arms (1)

Photobiomodulation

OTHER

• 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

Interventions

Phototherapy system CareMin650TMDEVICE

* 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.

Photobiomodulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient under guardianship or curatorship
  • Pregnant and breastfeeding woman
  • Allergy to polyurethanes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38439757BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Anne ZILLIOX, MD

    Institut de cancérologie Strasbourg Europe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire VIT

CONTACT

(0)3 68 33 95 23promotion-rc@icans.eu

Manon VOEGELIN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 22, 2024

Study Start

April 17, 2024

Primary Completion

September 17, 2025

Study Completion

September 17, 2025

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations

FR(1)