A study comparing two types of laser therapy to reduce mouth pain and inflammation caused by cancer treatment in children with leukemia

A randomized controlled trial comparing the efficacy of high-power and low-power laser therapy in the management of chemotherapy-induced oral mucositis in pediatric patients with acute lymphocytic leukemia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18078092

Enrollment

Registered

2025-05-23

Start date

2025-02-15

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced oral mucositis in pediatric patients with acute lymphocytic leukemia Oral Health

Interventions

Current interventions as of 08/08/2025: Participants will be randomly assigned to three groups. The first group will receive high-level laser therapy, the second group will receive low-level laser t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 08/08/2025: 1. Pediatric patients aged between 3 and 13 years 2. Presence of clinically evident oral mucositis 3. Reported oral burning sensation 4. Currently receiving chemotherapy according to the standard protocol including methotrexate, cytarabine, and dexamethasone 5. Clear clinical signs of mucositis-related inflammation 6. Performance status score >2 on the ECOG (Eastern Cooperative Oncology Group) scale, as published by ECOG-ACRIN in 1982 _____ Previous inclusion criteria: 1. Pediatric patients aged between 6 and 13 years 2. Presence of clinically evident oral mucositis 3. Reported oral burning sensation 4. Currently receiving chemotherapy according to the standard protocol including methotrexate, cytarabine, and dexamethasone 5. Clear clinical signs of mucositis-related inflammation 6. Performance status score >2 on the ECOG (Eastern Cooperative Oncology Group) scale, as published by ECOG-ACRIN in 1982

Exclusion criteria

Exclusion criteria: 1. Prior treatment with laser therapy for the management of oral mucositis 2. Presence of dysplastic lesions in the oral cavity 3. Patients receiving radiotherapy to the head and neck region

Design outcomes

Primary

Measure	Time frame
Oral mucositis severity measured using ChIMES, WHO Oral Mucositis Scale, NCI-CTC scale, and Modified Oral Assessment Guide (OAG) Scale at baseline, end of treatment, and one week post-treatment.	—

Secondary

Measure	Time frame
1. Weight measured using weighing scales at baseline and one week post-treatment 2. Absolute neutrophil count measured using CBC at baseline and one week post-treatment	—

Countries

Syria

Contacts

Public ContactLana Kassem

lann.aa1993@hotmail.com+963 935223292

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026