Evaluation the Efficacy of Photobiomodulation Therapy with 660 nm Diode Laser on Treatment of Radiotherapy- Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Determination of the Efficacy of Photobiomodulation Therapy with 660 nm Diode Laser on Treatment of Chemo radiotherapy- Induced Oral Mucositis in Head and Neck Cancer Pat
Design
Phase 3 double-blinded control trial on 30 patients, Randomisation was computerized with concealed randomization sequence carried out at an excel software
Settings and conduct
This study will be conducted on patients with oral mucositis induced by radiotherapy to the head and neck region in Shohadaye Tajrish Hospital, by randomization process, patients were divided into treatment (photobiomodulation therapy)and control (sham photobiomodulation therapy.
patients and outcome assessors were blinded to the treatment
Participants/Inclusion and exclusion criteria
Inclusion:
Patients with Karnofsky Performance Status equal to or more than 60%
Life expectancy equal to or more than 3 months
presence of Oral mucositis with at least grade 1
Exclusion:
previous radiotherapy to the head and neck
Systemic disease
Intervention groups
Patients with oral mucositis receiving photobiomodulation therapy with 660 nm diode laser
Main outcome variables
Grade of oral mucositis ( WHO scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230923059490N1
Registration date:2023-10-01, 1402/07/09
Registration timing:prospective
Last update:2023-10-01, 1402/07/09
Update count:0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
Neda Hakimiha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 396 4604
Email address
ned.hakimiha@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Efficacy of Photobiomodulation Therapy with 660 nm Diode Laser on Treatment of Radiotherapy- Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial
Public title
Evaluation of the effects of photobiomodulation therapy on oral ulcers induced by radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with equal or more than 60% Karnofsky Performance Status
Life expectancy equal or more than 3 months
Clinical confirmation of oral mucositis with minimum grade 1
Exclusion criteria:
Previous history of radiotherapy to head and neck region
Other systemic diseases
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We will generate random numbers using the Random Number Generation command in Excel. If these generated numbers are even, the patient is assigned to the intervention group, and if it is odd, the patient is assigned to the control group.Each of the groups to which 15 patients are compleieted, the generated numbers corresponding to that group are removed from the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
1. Patients: For all patients in both intervention and control groups photobiomodulation therapy with a diode laser will be done, but in the control group laser will be in off mode, and patients can't recognize the on or off status of the laser device due to wearing laser safety goggles.
2. Outcome assessor: the outcome assessor will be blind to the type of treatment that patients have received
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of laser application in medical sciences reseaerch center, shahid behe
Street address
Shohadaye tajrish hospital, Tajrish square.
City
Tehran
Province
Tehran
Postal code
1989934370
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.SBMU.LASER.REC.1402.016
Health conditions studied
1
Description of health condition studied
Oral mucositits induced by radiotherapy to head and neck
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Oral mucositis grade measured by WHO scale
Timepoint
Before intervention, during treatment session , 4 weeks after intervention
Method of measurement
WHO (World Health Organization) grading Scale for oral mucositis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with oral mucositis receiving photobiomodulation therapy with low level 660 nm diode laser
Category
Treatment - Devices
2
Description
Control group: Patients with oral mucositis receving sham photobiomodulation therapy (laser in off mode)