Effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients referring to Guilan(Rasht) dental college:A single- blind randomized clinical trial
Assessing he effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients
Design
Randomized single blinded clinical trial having control group,with parallel groups
Sample size:36 patients
Settings and conduct
Laser in areas affected by mucositis with a wavelength of 810 nm and time of 30 seconds per 1 cm2.Laser treatment begins on the day of diagnosis of mucositis and lasts for up to three consecutive days (a total of 4 days).Patients in the control group kept the mouthwash of Diphenhydramine + Almgs (50-50% in combination) at 15 ml every 6 hours for 30 seconds in the mouth and discharged. The investigator make the desired treatment, and the second person will be aware of the changes in both The team. A written agreement form for patients is completed.
Place of conducting trial is in surgery department of dental school
Participants/Inclusion and exclusion criteria
Inclusion criteria: head and neck cancer, receive chemotherapy regimen, oral mucositis stage3,4 .Exclusion criteria: Patients with open mouth limitation (less than 1cm2), relapse during treatment, taking any medication for the prevention and treatment of mucositis, inability to perform mucositis treatment and lack of oral hygiene observance.
Intervention groups
In the test group, Diode portable low-power
In the control group, combinational mouthwash
Main outcome variables
Evaluation of changes in pain and severity of lesion and patient's quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040863N1
Registration date:2018-12-03, 1397/09/12
Registration timing:retrospective
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Safa Motevasseli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 0862
Email address
safa.motevaseli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2018-11-04, 1397/08/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients referring to Guilan(Rasht) dental college:A single- blind randomized clinical trial
Public title
Effectiveness of Diode low-level laser therapy on treatment of mucositis induced by chemoradiotherapy in H&N cancer patients referring to Guilan(Rasht) dental college:A single- blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Head and neck cancer
Receiving Chemotherapy and Radiation Therapy
Getting oral mucositis stage3,4
Exclusion criteria:
Restricted opening of the mouth (less than 1cm2) that does not allow the use of laser on the tissue.
Relapse during treatment
Taking any medication to prevent and treat mucositis
Failure to perform mucositis treatment process
Inability to observe oral hygiene
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only participants are unaware of the allocation of study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences Research Center
Street address
End of the Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University Complex in Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4194173774
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.GUMS.REC.1397.096
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
The amount of pain
Timepoint
Laser: From the onset of the lesion / Day 4 ofTreatment / One week after treatment. mouthwash: From the beginning of the lesion for one month.
Method of measurement
Based on the VAS index
2
Description
severity of lesion
Timepoint
Laser: From the onset of the lesion / Day 4 ofTreatment / One week after treatment. mouthwash: weekly From the beginning of the lesion for one month.
Method of measurement
Based on the WHO
3
Description
length of treatment
Timepoint
Sum of Severity of Mucositis Severity of Days from the onset of symptoms of grade 3 and 4
Method of measurement
number of days
4
Description
quality of life
Timepoint
Laser: From the onset of the lesion / Day 4 ofTreatment / One month after treatment. mouthwash:weekly From the beginning of the lesion for one month.
Method of measurement
based on FACT_HN & OMWQ _ HN
Secondary outcomes
empty
Intervention groups
1
Description
Control group: combined mouthwash: kept the mouthwash of Diphenhydramine + Almgs (50-50 in combination) at 15 ml every 6 hours for 30 seconds in the mouth and then spitting
Category
Treatment - Drugs
2
Description
Intervention group: low_level Diode laser:The laser is applied in mucositis areas with a wavelength of 810 nm and a time of 30 seconds per 1 cm2
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral and maxiofacial Surgery, Faculty of Dentistry, Gilan
Full name of responsible person
Safa Motevasseli
Street address
End of Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6416
Email
smotevasselee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Safa Motevasseli
Street address
End of Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 21 3348 6416
Email
smotevasselee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadi Barati
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ansarieh
City
Zanjan
Province
Zanjan
Postal code
4515755589
Phone
+98 13 3348 6416
Email
shadi.barati1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Safa Motevasseli
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
End of Lacan Road - 2 Km to Fouman - Facing Caspian Restaurants and Facade - University of Guilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 3348 6416
Email
smotevasselee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadi Barati
Position
Dentistry student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ansariyeh
City
Zanjan
Province
Zanjan
Postal code
4515755589
Phone
+98 13 3348 6416
Email
shadi.barati137@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
preserve Secrets of the patients
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available