Thirty patients with bilateral chemotherapy induced oral mucositis older than 6 years old with consent form will enrolled in the study. Lesions in each patient will be accidentally divided to two groups of intervention side and control side. Both sides will be applied by methylen blue. After 10 min for activation of this dye, low level laser (Azor-ZK-OZ number 242 made in Russia) will be used. Photodynamic therapy will be started from emerging the first manifestation of chemotherapy induced mucositis on day 1, 3, 5. Laser irradiation with low level laser with 660 nm wave length, 19.2 J/cm2 dose for 10 min will be performed.
Control side will be irradiated by sham laser. The patients will be followed a week after last session of photodynamic therapy (day12) . Patients and the researcher who measures the scores are blind to the each group treatment (double blind).The participants will be randomized accidentally by block randomization.
Each patient will be examined by an oral medicine specialist and size and mucositis grade of oral lesion will be evaluated according to WHO and NCI scores every session before starting photodynamic therapy and before follow up session on day 12.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707108585N4
Registration date:2017-08-15, 1396/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-21, 1396/03/31
Expected recruitment end date
2017-10-01, 1396/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of photodynamic therapy on pain and size of chemotherapy induced mucositis
Public title
The effect of photodynamic therapy on mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with bilateral chemotherapy induced mucositis; patients over 6 years old; sign the consent form
Exclusion criteria: Patients with diabetic mellitus; allergic to the Methylen blue stain
Age
From 6 years old to 139 years old
Gender
Both
Phase
1-2
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand street, Shiraz, Fars
City
Shiraz
Postal code
Approval date
2017-06-11, 1396/03/21
Ethics committee reference number
IR.SUMS.REC.1396.61
Health conditions studied
1
Description of health condition studied
chemotherapy induced oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
size of lesion
Timepoint
day1,3,5,12
Method of measurement
NCI score
2
Description
pain, disability
Timepoint
day1,3,5,12
Method of measurement
WHO score
3
Description
weight of patient
Timepoint
day1,3,5,12
Method of measurement
balance
Secondary outcomes
empty
Intervention groups
1
Description
Interventional side:
In interventional side, photodynamic therapy will be started from emerging the first manifestation of mucositis induced by chemotherapy, every other day for 3 times. Methylen blue (MB) will be used for photodynamic therapy and low level laser(LLL) [Azor-ZK-OZ number 242 made in Russia] will be applied for activation of this vital stain. After dilution of Methylen blue(0.05 mg/ml), it will be applied to lesions and after ten minutes low level laser with wave length 660 nm, power 25mw and dose 19.2 J/cm2 will be radiated on oral lesions of participants for 10 min.
Category
Treatment - Other
2
Description
Control side:
In the control side after dilution of methylen blue (0.05 mg/ml), it will be applied to lesions and after ten minutes patients will receive sham laser.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz university of Medical Science, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Other areas of specialty/work
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3631 9309
Fax
Email
lavaeef@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Other areas of specialty/work
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3631 9309
Fax
Email
lavaeef@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Other areas of specialty/work
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3631 9309
Fax
Email
lavaeef@sums.aac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)