The effect of Indocyanine green mediated photodynamic therapy in combination with low level laser therapy on pain and size of chemotherapy induced oral mucositis
Determination the effect of indocyanine green mediated photo dynamic therapy in combination with laser therapy on chemotherapy induced oral mucositis
Design
In this randomized, blinded, clinical trial, Patients with oral mucositis will be enrolled in two groups by block randomization. In intervention group 20 patients will receive photodynamic therapy from emerging the first manifestation of oral mucositis induced by chemotherapy, once a week for 4 weeks. In control group 20 patients will receive the sham laser. The pain and size of the lesions will be evaluated according to WHO and NCI scores.This study is the third phase of clinical trial.
Settings and conduct
This randomized clinical study will be done on 40 patients with acute leukemia who are admitted in Namazee and Amir hospitals and are under chemotherapy during 2022-2023.The investigator who evaluate the pain and size of lesions, and the data analyzer are blind to the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients above 8 years old with chemotherapy induced oral mucositis who sign the consent form will be included.
Exclusion criteria: patients under chemotherapy for any reason except acute leukemia, allergic to the Indocyanine green stain, having diabetes mellitus, and refuse to sign the consent form will be excluded.
Intervention groups
Photodynamic therapy will be started from emerging the first manifestation of oral mucositis induced by chemotherapy, once a week for 4 weeks. indocyanine green will be used for photodynamic therapy and low level laser will be applied for activation of this vital stain. after dilution of indocyanine green (0.1 mg/ml) the patients will gargle it and after 10 minutes, a low level laser with wave length of 808 nm and a dose 50 J/cm² will be radiated on an oral lesion on non-keratinized mucosa of participants.
Main outcome variables
Pain; size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N16
Registration date:2022-12-04, 1401/09/13
Registration timing:prospective
Last update:2022-12-04, 1401/09/13
Update count:0
Registration date
2022-12-04, 1401/09/13
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
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Indocyanine green mediated photodynamic therapy in combination with low level laser therapy on pain and size of chemotherapy induced oral mucositis
Public title
The effect of photodynamic therapy on oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 8 years old
Patients with intact mucosa at the beginning of the study
Patients with chemotherapy induced oral mucositis
Patients signing the consent form
Exclusion criteria:
Patients under chemotherapy for any reason except acute leukemia
Patient who are allergic to the Indocyanine green stain
Patients with diabetes mellitus
Patients refusing to sign the consent form
Age
From 8 years old to 99 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Each block with 4 allocations, consisting of 2 allocation for intervention and 2 for control group, will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 40 participants (10 blocks).
The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 40 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on the order of enrollment.
Blinding (investigator's opinion)
Double blinded
Blinding description
One of the researchers will prescribe the treatment and another researcher will assess the outcome. Therefore, the researchers will be blind. The statistical analyzer will be blind to the type of treatment in each group. The outcome assessor, patients and statistical analyzer will be blind to the prescribed treatment.
Both groups of patients will receive chlorhexidine and nystatin as routine treatment. The patients in the intervention group will receive low level laser, but the patients in control group will receive sham laser.
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
Province
Fars
Postal code
1433671348
Approval date
2022-09-12, 1401/06/21
Ethics committee reference number
1401.480.IR.SUMS.REC
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
The level of pain and disability
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21, and 28 days after the start
Method of measurement
WHO index
2
Description
Size of lesion
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14, 21, and 28 days after the start
Method of measurement
NCI Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In interventional group, photodynamic therapy will be started from emerging the first manifestation of mucositis induced by chemotherapy, once a week for 4 weeks. Indocyanine green will be used for photodynamic therapy and low level laser(LLL) will be applied for activation of this vital stain. After dilution of Indocyanine green (0.1 mg/ml), it will be applied to lesions and after ten minutes low level laser with wave length 808 nm and dose of 50 J/cm2 will be radiated on oral lesions of participants.
Category
Treatment - Other
2
Description
Control group: In the control group, after dilution of Indocyanine green(0.1mg/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
Namazee hospital
Full name of responsible person
Fatemeh Lavaee
Street address
Namazee Sq, Zand St, Namazi hospital
City
Shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Amir oncology hospital
Full name of responsible person
Fatemeh Lavaee
Street address
Station 11, Fahang shahr
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3532
Email
amirhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fars Province Governor Office
Full name of responsible person
Mohammad Hadi Imanieh
Street address
Imam Hossein Sq.
City
Shiraz
Province
Fars
Postal code
7134858888
Phone
+98 71 3233 8025
Email
Info@farsp.ir
Grant name
Grant code / Reference number
15398-216959
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fars Province Governor Office
Proportion provided by this source
100
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be shared after deidentification of participants.
When the data will become available and for how long
6 months after publication data will become available.
To whom data/document is available
The researchers in academic institutions
Under which criteria data/document could be used
The researchers in academic institutions
From where data/document is obtainable
The researchers in academic institutions can email responsible person and request information.
What processes are involved for a request to access data/document
The researchers in academic institutions can email responsible person and request information.