Clinical trial NCT05452668: Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients
Official title: Effectiveness of Laser Therapy of Different Wavelengths in Chemotherapy Induced Oral Mucositis in Children With Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Mucositis
Childhood Acute Lymphoblastic Leukemia
Keywords: Oral Mucositis
Childhood Acute Lymphoblastic Leukemia
Laser therapy
low level laser therapy
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 51
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Oral mucositis is one of the most frequent complications associated with chemotherapy, occurring in up to 90% children receiving treatment for cancer. Different treatment modalities have been suggested with inconsistent results. Recently, it has been suggested that the use of laser could reduce the grade of oral mucositis and alleviate the symptoms.

Aim: To evaluate and compare the efficacy between the high (Infrared) wavelength laser and low (red) wavelength laser in management of chemotherapy induced oral mucositis in children with acute lymphoblastic leukemia.

Methods: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups. Group I: will be treated with Laser wavelength 660 nm, group II: will be treated with laser wavelength 970 nm, and group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission. All the patients will follow the hospital standard management for oral mucositis. All patients will be assessed for pain score using CHIMES, oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11. As well as measuring the duration of the lesion.

Detailed description: This study is a randomized, prospective, double-blind trial that will include acute lymphoblastic leukemia inpatients receiving induction chemotherapy between the age of 3 and 14 years who develop oral mucositis grade 2 or more. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into three groups.

Group I: will be treated with Laser wavelength 660 nm, Group II: will be treated with laser wavelength 970 nm, Group III: will receive mock treatment which is the exact repetition of the treatment modality but without any laser emission.

All the patients will follow the hospital standard management for oral mucositis.

All patients will be assessed for

1. Pain score using CHIMES,
2. Oral mucositis using NCI-CTCAE scale V5 on days, 0,4,7 and 11.
3. Measuring the duration of the lesion.

Eligibility criteria: Inclusion Criteria:

1. Patients with Acute Lymphoblastic Leukemia in the induction therapy phase and have oral mucositis grade 2 or more.
2. Age: 3-14 years old of both genders.
3. No previous treatment with laser.
4. Ability to open mouth for more than 2 cm for the duration of laser application with a level of cooperation (Frankl rating 3 or 4).
5. Patients who still have 10 days in their induction therapy phase or can be followed up for a mininum of 10 days after the development of oral mucositis

Exclusion Criteria:

1. Patients receiving radiotherapy
2. Received oral Cryotherapy or IV keratinocyte growth factor for oral mucositis
3. Patients with unstable clinical condition (e.g. sepsis)
4. Patients who will be withdrawn from participation according to their request or due to loss in follow up

Primary outcomes:
measure: Pain Assessment
timeFrame: 4 days
Secondary outcomes:
measure: Oral Mucositis Severity:
timeFrame: 4 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children Cancer Hospital Egypt 57357
city: Cairo
country: Egypt
facility: Children Cancer Hospital in Egypt 57357
Study officials:
affiliation: NewGiza University
name: Hussein ElNoury, MSc
role: PRINCIPAL_INVESTIGATOR
References: