Determination of the preventive effect of low level laser on radiation-induced xerostomia in patients with head and neck cancer
Design
A randomized, Double blinded, controlled clinical trial with purposive sampling with a parallel group design of 34 patients.
Settings and conduct
Imam Reza oncology and radiotherapy canter and Imam Reza hospital
blindness of patients and Outcome assessor about study group
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age range:20-75 Yrs
2. Suffering from head and neck tumors requiring radiotherapy
3. Involving one of major salivary glands in radiation field
4. Total dose exceeding 20 Gry
Exclusion criteria
7-
1. Patient or physician dissatisfaction
2. Suffering from minor or major salivary gland tumors
3. Suffering from any systemic disease with potential of xerostomia or consumption of any drug causing xerostomia
4. Presence of xerostomia in initial examination(unstimulated saliva<0.1 ml/min)
5. History of previous radiotherapy
6. Presence of oral mucosal lesions
7. Regration of patient during trial
Intervention groups
In intervention group we use GaAlAs LLL with 810 nm, 200 mw power,3 cm penetration depth using dose 2 j/cm2 ,on 16 points including: 3 points on each parotid gland,2 points on each sublingual gland,1 point on each sublingual gland and 2 points on each buccal mucosa by continuous wave and contact mode. Laser is used 3 days in week for 4 weeks beginning at the first day of radiotherapy.In control group sham laser is used .
Main outcome variables
subjective xerostomia;stimulated and unstimulated saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080906001216N3
Registration date:2020-06-14, 1399/03/25
Registration timing:retrospective
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Pegah Mosannen Mozaffari
Name of organization / entity
research center of Mashhad dental faculty,Mashhad University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 513882950115
Email address
mosannenp@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research of Mashhad University of Medical Sciences
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the preventive effects of low level laser in head and neck radiotherapy induced xerostomia-a clinical trial
Public title
The effect of laser on radiation-induced xerostomia in patients with head and neck cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range:20-75 Yrs
Suffering from head and neck tumors requiring radiotherapy
Involving one of major salivary glands in radiation field
Total dose exceeding 20 Gry
Exclusion criteria:
Patient or physician dissatisfaction
Suffering from minor or major salivary gland tumors
Suffering from any systemic disease with potential of xerostomia or consumption of any drug causing xerostomia
Presence of xerostomia in initial examination(unstimulated saliva<0.1 ml/min)
History of previous radiotherapy
Presence of oral mucosal lesions
Regration of patient during trial
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients do not know whether the laser is on or off. a unique laser system is used in both groups. two groups never meet each other . all protocols are similar.laser safety actions are similar in both groups.in sham laser group a beep sound is played by mobile so that the patint per cive switching the laser beam while le has safety goggles and tha mobile is not in visual field. in laser group the system is really switched on and off.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committee of Mashhad university of medical sciences
Street address
vice chancellor of research of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
911735984
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.MUMS.REC.1394.251
Health conditions studied
1
Description of health condition studied
Radiation-induced xerostomia
ICD-10 code
R68.2
ICD-10 code description
Dry mouth, unspecified
Primary outcomes
1
Description
stimulated and unstimulated saliva
Timepoint
before radiotherpay and once weekly during radiotherpay ( mean: 6 weeks) on 8 to 10 a.m.
Method of measurement
Unstimulated saliva: during 5 minutes,whole saliva was sputed in glass tube (every 60 minutes , 5 times).saliva was measured in mili liters and grams stimulated saliva: saliva stimulation in 0,30,60,90 and 120 seconds by citric acid 2% soaked swab on lateral borders of tongues
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: GaAlAs Low level laser (LLL ) with 810 nm, 200 mw power,3 cm penetration depth using dose 2 j/cm2 ,on 16 points including: 3 points on each parotid gland,2 points on each sublingual gland,1 point on each sublingual gland and 2 points on each buccal mucosa by continuous wave and contact mode.
Category
Prevention
2
Description
Control group: The laser device is used off
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Imam Reza Hospital and Reza Radiotherapy-Oncology center