Evaluation of low level laser effect in Prevention of
chemotherapy-induced mucositis in patients with cancer referred to Emam Ali hospital in year 1389
The aim of this study is to evaluate low level laser effect in prevention of chemotherapy induced mucositis. This is a Double Blind Randomized Clinical Trial in which, 60 patients who have over 6 months hope for life and platelet count more than 100000 are randomly assigned into intervention or control group. The patients in the intervention group will receive 30mw laser in 10 points of the mouth before every period of chemotherapy while the control group will receive extinct laser with the same period of time. The patients in both groups will be visited every 2 weeks during laser therapy (6 months) and 2 weeks after the intervention and intensity of oral muscositis by using WHO standard scale from 0-4, Xerostomia by LENT SOMA scale from 1-4, and pain score by VAS from 0-10 will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811033133N1
Registration date:2010-11-20, 1389/08/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-20, 1389/08/29
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2010-06-01, 1389/03/11
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of low level laser effect in Prevention of
chemotherapy-induced mucositis in patients with cancer referred to Emam Ali hospital in year 1389
Public title
Evaluation of low level laser effect in prevention of oral mucositis in patients with cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with Karnofsky Performance status equal or more than 60, hope for life more than 6 months, absence of previous chemotherapy toxicity, WBC count equal or more than 1500, platelet count equal or more than 100000 /ml, patients who sign informed consent
Exclusion criteria: Simultaneous radio therapy with chemotherapy or previous radiotherapy in head and neck, head and neck surgery cause of malignancy, Denture or something like that, Pregnancy, infection
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Reseach, Zahedan University of Medical Sciences
Street address
Vice-chancellor for Reseach, Zahedan University of Medical Science, Khalije Fars Highway
City
Zahedan
Postal code
Approval date
2010-07-04, 1389/04/13
Ethics committee reference number
89-1149
Health conditions studied
1
Description of health condition studied
Chemotherapy Induced Mucositis
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Oral Mucositis
Timepoint
Every 14 days
Method of measurement
WHO standard scale( 0-4)
Secondary outcomes
1
Description
Xerostomia
Timepoint
Every 14 days
Method of measurement
LENT SOMA scale (1-4)
2
Description
Pain
Timepoint
Every 14 days
Method of measurement
VAS
Intervention groups
1
Description
In study group 30 mw laser with wave length 630 nm and 5j/cm2 dosage was used in ten points of the mouth.
Category
Prevention
2
Description
In control group sham laser was used in ten points of the mouth.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.H.Mahmudzade Sagheb
Street address
Zahedan University of Medical Sciences, Khalije Fars Highway
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Vice-chancellor for Reseach
Full name of responsible person
Dr. Abasalt Borji
Position
Vice-chancellor for Reseach
Other areas of specialty/work
Street address
Zahedan University of Medical sciences, Khalije Fars Highway
City
Zahedan
Postal code
Phone
+98 54 1341 6706
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Fateme Arbabi Kalati, Dr. Farshid Arbabi Kalati
Position
Assistant Professor, Assistant Professor
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences- Khalije Fars Highway