NCT06267417Completed
Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies
Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
Introduction: Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM. Aim: To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers. Methods: This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 24 Jul 2023
- Start date
- 10 Apr 2023
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Diseases
- Childhood cancers
- NCT number
- NCT06267417
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 10 Apr 2023 to the primary completion date, 1 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation.
Other
- Patients with dysplastic oral lesions.
Who the study is looking for
- pediatric patients diagnosed with Acute Myeloid Leukemia.
- Children with a minimum age of 3 years and a maximum 18 years.
- Children with sufficient cooperation to accept the treatment and evaluation periods
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children Cancer Hospital 57357 Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.