Evaluating the pain relieving effects of single session of Non-Thermal CO2 Laser Therapy (NTCLT) in patients with chemotherapy induced oral mucositis (COM).
Design
This study is a before-after clinical trial (phase 2) on 20 patients.
Settings and conduct
Before laser irradiation, a layer of a gel with a thickness of 3–4 mm was placed on each lesion. It is a transparent gel, with high water content (87.5%) and without any anesthetic properties. The CO2 laser (λ = 10,600 nm; Lancet-2, Russia) was operated at 1W power, in continuous mode, with a de-focused hand piece, 5-6 mm distance from the surface of the gel, scanning rapidly over the lesion with a circular motion.
The patients scored and recorded the contact and non-stimulate (non -contact) pain severity of their lesions. These scores were also recorded post-operatively at 4, 8, hours and then daily up to 7 days according to VAS (Visual analogue scale) scores. Any kind of adverse effects were recorded.
This study was conducted at Medical Laser Research Center, ACECR, collaboration with cancer treatment centers.
Participants/Inclusion and exclusion criteria
Patient selection criteria:
• Chemotherapy-induced oral mucositis with WHO grade ≥ 2
• The minimum literacy to read and write and filling the forms
• More than 18 years old
• Providing written informed consent after the physician's explanation about the treatment method
Criteria for not selecting patients:
• Pregnancy
• Breastfeeding
• History of Photo sensitivity or taking photo sensitizing drugs
• Head and neck radiotherapy
• Use of narcotic painkillers
Intervention groups
Patients with chemotherapy-induced oral mucositis with WHO grade ≥ 2
Main outcome variables
1- Non-contact pain score
2- Contact pain score
General information
Reason for update
Acronym
NTCLT
IRCT registration information
IRCT registration number:IRCT20220220054073N1
Registration date:2023-06-27, 1402/04/06
Registration timing:retrospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
Nasrin Zand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0221
Email address
zand_nas@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2015-04-21, 1394/02/01
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-05-05, 1398/02/15
Scientific title
Evaluating the pain relieving effects of Non-Thermal CO2 Laser Therapy (NTCLT) on chemotherapy induced oral mucositis
Public title
Evaluating the pain relieving effects of Non-Thermal CO2 Laser Therapy (NTCLT) on chemotherapy induced oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chemotherapy-induced oral mucositis with grade 1-4 according to the WHO classification index
The minimum literacy to read and write and filling the forms
Providing written informed consent after the physician's explanation about the treatment method
Exclusion criteria:
Pregnancy
Breastfeeding
History of Photo sensitivity or use of photo sensitizing drugs
Head and neck radiotherapy
Taking narcotic painkillers
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
1
According to the number of painful oral lesions which can be irradiated by NTCLT
Actual sample size reached:
17
More than 1 sample in each individual
Actual sample size in each individual:
2
According to the number of painful oral lesions which can be irradiated by NTCLT
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Before-After Clinical Trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan Institute
Street address
No 15. Royan Alley, East Hafez St., end of North Bani Hashem St., Shahid Soleimani Highway (Resalat), Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1665659911
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
EC/93/1103
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced oral mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
Description
Non-contact (Non-stimulate) pain score
Timepoint
before laser irradiation, immediately after laser irradiation, 4 hours, 8 hours after laser irradiation and then daily until the seventh day
Method of measurement
(Visual analogue scale) VAS
2
Description
Contact pain score
Timepoint
before laser irradiation, immediately after laser irradiation, 4 hours, 8 hours after laser irradiation and then daily until the seventh day
Method of measurement
(Visual analogue scale) VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with chemotherapy-induced oral mucositis. In this before-after clinical trial, the patients were irradiated with a single session of NTCLT. At first, the surgical staff and the patient put on protective eyeglasses. Then, the lesion and its surrounding tissue were covered with a thick layer (3-4 mm) of a non-anesthetic, completely transparent gel containing very high percentage (87.5%) of water (Abzar Darman Co., Iran). (This gel is routinely used for gastrointestinal endoscopy as a lubricating agent, sonography, etc.) Before the initiation of laser irradiation, the patient and surgical staff put on appropriate safety goggles. The CO2 laser (wavelength: 10600 nm; Lancet-2, Russia) beam (power: 1 Watt, in continuous mode) was irradiated through the gel layer. The lesion was scanned with rapid circular motion of the handpiece over the lesion, while the distance of the tip of the defocused handpiece from the surface of the gel was about 5-6 mm. The laser beam was illuminated to a circle area of the lesion (with a diameter of approximately 1cm) for 5 seconds in each pass. If the contact pain of the lesion persisted, the procedure was repeated again. The gel layer was gently wiped between the passes, and a new layer of gel was placed on the lesion.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamed Cancer Istitute, ACECR
Full name of responsible person
Dr. Safa Najjar Najafi
Street address
No. 45, Vahidnazari St., Aborihan St., Enqebal St
City
Tehran
Province
Tehran
Postal code
1315685981
Phone
+98 21 6640 4050
Email
safa3n@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation (INSF)
Full name of responsible person
Dr. Ali Mohammad Soltani
Street address
No. 33, 5th St., North Karegar Ave
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8800 3981
Email
info@insf.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation (INSF)
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
Iranian academic center for education culture and research
Full name of responsible person
Dr. Nasrin Zand
Position
Faculty Member, Asistance Prof
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 17, Nazari St., Palestine St., Enqelab St
City
Tehran
Province
Tehran
Postal code
1315795611
Phone
+98 21 6649 4649
Email
zand_nas@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Nasrin Zand
Position
Faculty Member, Assistant Prof
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 17, Nazari St., Palestine St., Enqelab St
City
Tehran
Province
Tehran
Postal code
1315795611
Phone
+98 21 6649 4649
Email
zand_nas@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr. Nasrin Zand
Position
Faculty Member, Asistance Prof
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 17, Nazari St., Palestine St., Enqelab St
City
Tehran
Province
Tehran
Postal code
1315795611
Phone
+98 21 6649 4649
Email
zand_nas@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
1- Study protocol, statistical analysis map, clinical study report
2- Informed consent form
When the data will become available and for how long
1- After confirming the conclusion of the project by the sponsor
2- At the time of reviewing the final report
To whom data/document is available
1- Free access to the article
2- The sponsor
Under which criteria data/document could be used
1- To conduct research and cite the source
2- To check compliance with the principles
From where data/document is obtainable
1- Internet
2- Project administrator
What processes are involved for a request to access data/document
1- Download the article according to the rules of the journal
2- Request from the administrator