A study comparing two types of laser therapy to reduce mouth pain and inflammation caused by cancer treatment in children with leukemia
| ISRCTN | ISRCTN18078092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18078092 |
| Secondary identifying numbers | 2931 |
- Submission date
- 16/05/2025
- Registration date
- 23/05/2025
- Last edited
- 08/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
This study aims to compare the effectiveness of two types of laser therapy (high-level and low-level) in treating chemotherapy-induced oral mucositis in children with acute lymphocytic leukemia. The goal is to find out which treatment helps reduce pain and improve healing better.
Who can participate?
Children between the ages of 6 and 13 who are receiving chemotherapy for acute lymphocytic leukemia and have developed oral mucositis can take part.
What does the study involve?
Participants will receive one of three treatments: high-level laser therapy, low-level laser therapy, or a placebo treatment. Their progress will be monitored over several sessions to evaluate how well each treatment works.
What are the possible benefits and risks of participating?
Participants may benefit from reduced pain and faster healing of oral mucositis. Risks are minimal but may include temporary discomfort from the laser treatment.
Where is the study run from?
The Children’s University Hospital, Damascus University, in the Hematology Department.
When is the study starting and how long is it expected to run for?
May 2024 to November 2025
Who is funding the study?
Investigator initiated and funded.
Who is the main contact?
Lana Kassem, Lann.aa1993@hotmail.com
Contact information
Dr Lana Kassem
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
Floor 1 Badeer St
Damascus
-
Syria
| Phone | +963 935223292 |
|---|---|
| lann.aa1993@hotmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | ISRCTN18078092 PIS استمارتي4vvvvvvvvvvv.pdf |
| Scientific title | 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 |
| Study objectives | The study hypothesizes that there is a difference in the efficacy of high-level laser therapy, low-level laser therapy, and placebo in the management of chemotherapy-induced oral mucositis in pediatric patients with acute lymphocytic leukemia. These differences are expected to be observed across three assessment time points: baseline, end of treatment, and one week post-treatment |
| Ethics approval(s) |
Approved 12/08/2024, National Committee for Ethics of Scientific Knowledge and Technology, High Commission for Scientific Research, Syria (Damascus, Al-Sabe’ Bahrat (Seven Lakes) – Former Prime Minister’s Office Building, Syria, Damascus, 30151, Syria; +963-11-3341864; manager@hcsr.gov.sy), ref: 2931 |
| Health condition(s) or problem(s) studied | Chemotherapy-induced oral mucositis in pediatric patients with acute lymphocytic leukemia |
| Intervention | 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 therapy, and the third group will receive a placebo (sham laser). The treatment will be applied once daily for a specified number of days during episodes of chemotherapy-induced mucositis. Laser parameters (power, wavelength, and duration) will be standardized for each group according to the intervention protocol. Outcomes will be assessed before treatment, at the end of treatment, and one week post-treatment. Randomization Method: Random allocation was performed using the GraphPad online tool. High-Power Laser Protocol: Type: Class IV Diode Laser (Doctor Smile) – Italy Wavelengths: Combined 635–980 nm Average Power: 2.75 W (5 W pulsed at 50%) Area: 0.785 cm² Application Time: 240 seconds per session Total Energy per Session: 660 J Energy density: 840 J/cm² Application Mode: Defocused, non-contact, continuous wave, rotatory movement Application Technique: Uniform sweeping rotatory motion with the tip approximately 1 cm from tissue, positioned orthogonally Treatment Frequency: Once daily for four consecutive days Target Area: Entire oral mucosa, including ulcerated, erythematous, and clinically unaffected sites Wavelength Delivery: Combined wavelengths delivered simultaneously Low-Level Laser Therapy (LLLT) Protocol: Laser Type: Class IV Diode Laser (Doctor Smile) – Italy Wavelengths: Combined 635–980 nm Average Power: 0.25 W Dose per Session: 60 J Area: 0.785 cm² Fluence (Energy Density): 76.43 J/cm² Application Time: 240 seconds per session Mode: Defocused, non-contact, continuous wave mode, rotatory movement _____ Previous interventions: 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 therapy, and the third group will receive a placebo (sham laser). The treatment will be applied once daily for a specified number of days during episodes of chemotherapy-induced mucositis. Laser parameters (power, wavelength, and duration) will be standardized for each group according to the intervention protocol. Outcomes will be assessed before treatment, at the end of treatment, and one week post-treatment. Randomization Method: Random allocation was performed using the GraphPad online tool. High-Power Laser Therapy (HPLT) Protocol - Laser Type: Class IV Diode Laser (Doctor Smile) - Wavelengths: Combined 660–970 nm - Power Output: 3.2 W (6.4 W pulsed at 50%) - Average Power: 3.2 W - Pulse Frequency: 1–20,000 Hz - Spot Size: 1 cm² - Application Time: 231 seconds per session - Total Energy per Session: 810 J - Total Dose: 810 J per session - Application Mode: Defocused, non-contact, continuous wave, rotatory movement - Application Technique: Uniform sweeping rotatory motion with the tip approximately 1 cm from tissue, positioned orthogonally - Treatment Frequency: Once daily for four consecutive days - Target Area: Entire oral mucosa, including ulcerated, erythematous, and clinically unaffected sites - Wavelength Delivery: Combined wavelengths delivered simultaneously Low-Level Laser Therapy (LLLT) Protocol - Laser Type: Class IV Diode Laser (Doctor Smile) - Wavelengths: 660 nm and 970 nm (combined) - Power Output: 320 mW (0.32 W) - Irradiance (Power Density): 320 mW/cm² - Fluence (Energy Density): 36.8 J/cm² - Spot Size: 1 cm² - Energy per Area (per site): 16 J - Application Time per Site: 50 seconds - Total Number of Treated Areas: 9 intraoral sites - Upper lip - Lower lip - Right cheek - Left cheek - Right lateral tongue - Left lateral tongue - Hard palate - Soft palate - Floor of the mouth - Total Session Time: 450 seconds (7 minutes and 30 seconds) - Application Mode: Defocused, non-contact, continuous wave mode, rotatory movement, tip held orthogonally to mucosal surface at a distance of approximately 1 cm - Treatment Frequency: Once daily for four consecutive days - Target Population: Pediatric patients undergoing chemotherapy for Acute Lymphoblastic Leukemia (ALL) |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doctor Smile laser therapy device |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 15/05/2024 |
| Completion date | 30/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/02/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Hematology and Oncology Unit - General Authority of the Children's University Hospital – Damascus
Mezzeh Highway, adjacent to Al-Mowasat University Hospital
Damascus
-
Syria
Damascus
-
Syria
Sponsor information
Damascus University
University/education
University/education
Mezzeh Highway
Damascus
-
Syria
| Phone | +963 993303359 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
Investigator initiated and funded
No information available
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and presentation at relevant scientific conferences. |
| IPD sharing plan | The datasets generated and analysed during the current study will be available upon request from Lana Kassem, Lann.aa1993@hotmail.com. The shared data will include individual participant data related to treatment outcomes and clinical assessments. Data will be anonymized to protect participant confidentiality. Data sharing will be granted for research purposes only, following ethical approval and with appropriate data use agreements. The data will be available starting from the publication date and for a period of five years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Arabic | 23/05/2025 | No | Yes |
Additional files
Editorial Notes
08/08/2025: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The interventions were changed.
3. The target number of participants was changed from 18 to 30.
16/05/2025: Study's existence confirmed by the Dean of the Faculty of Dentistry, Department of Oral Medicine.
