Comparison & Evaluation Of Localized & Generalized Effect of Using Propolis On Oral Mucositis Resulting From Radiotherapy with placebo; Randomized Clinical Trial
72 patients with head and neck cancer are randomly divided into 3 groups. A: local use of propolis and systemic use of placebo B: systemic use of propolis and local use of placebo C: local and systemic use of placebo
they starts using the mouthwash and drugs, when starting the radiotherapy and stops 2 weeks after finishing their radiotherapy. oral signs are recorded by a blind researcher based on WHO scales. ELISA kits are used to analyze TNF in saliva at baseline and at the end of radiotherapy.
Participants/Inclusion and exclusion criteria
head and neck cancer
requiring radiotherapy
mucositis
exclusion criteria: weak patients' cooperation
allergic reaction to propolis
Intervention groups
Local use of propolis and systemic use of placebo, Local use of placebo and systemic use of propolis, Local and systemic use of placebo
Main outcome variables
Local or systemic use of propolis, Severity of mucositis, Incidence of mucositis, Onset of mucositis, Measurement of TNF-α in saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030475N4
Registration date:2019-07-21, 1398/04/30
Registration timing:retrospective
Last update:2019-07-21, 1398/04/30
Update count:0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
Mitra Askari
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1131
Email address
m-askari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
2015-08-23, 1394/06/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2018-03-21, 1397/01/01
Scientific title
Evaluating and comparing the effect of systemic and local use of Propolis in oral mucositis resulting from radiotherapy
Public title
effect of propolis on oral mucositis resulting from radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
head and neck cancer
requiring radiotherapy
mucositis
Exclusion criteria:
weak patients' cooperation
allergic reaction to propolis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
83
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, Randomization Unit: individual, Randomization tool: random number table. There is not allocation concealment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
the producing company were asked to produce the propolis pills and placebo pill with the same apperance. Propolis and placebo mouthwash were also produced with the same color and in the same bottels. the drugs were divided into 3 seperate groups. one contianing placebo pills and propolis mouthwash, one contianing placebo mouthwash and propolis pills and the other one containing placebo pills and mouthwash. on each bottel nomber 1, 2 or 3 were written. in a sealed letter the content of each group were revealed. patients , researcher and statistic expert were blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehranrsity of Medical Sciences
Street address
tehran TUMS complex
City
tehran
Province
Tehran
Postal code
1212232334
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
IR.TUMS.REC.1395.2647
Health conditions studied
1
Description of health condition studied
Oral mucositis (ulcerative) due to radiation
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
mucositis severity and percentage
Timepoint
baseline / 2 weeks after completing radiotherapy
Method of measurement
based on WHO
2
Description
incidence of mucositis
Timepoint
baseline
Method of measurement
starts 1-2 weeks after radiotherapy and is determined by clinical assessment.
3
Description
TNF in saliva
Timepoint
baseline/ 2 weeks after completing radiotherapy
Method of measurement
ELISA Kis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: local propolis and systemic placebo
Category
Treatment - Drugs
2
Description
Intervention group: systemic propolis and local placebo
Category
Treatment - Drugs
3
Description
Control group: local and systemic placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye- haft-e tir hospital
Full name of responsible person
mitra askari
Street address
shahid rajaii street
City
rey city
Province
Tehran
Postal code
2324545465
Phone
+98 21 5590 9051
Email
iranunivercity@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mitra askari
Street address
tehran TUMS complex
City
tehran
Province
Tehran
Postal code
1212232334
Phone
+98 21 8898 7667
Email
M_askari@Sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arayeh maleki
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
TUMS complex
City
tehran
Province
Tehran
Postal code
1212232334
Phone
+98 21 8898 7667
Email
maleki.arayeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
arayeh maleki
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
tehran TUMS complex
City
tehran
Province
Tehran
Postal code
1212232334
Phone
+98 21 8898 7667
Email
maleki.arayeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
arayeh maleki
Position
general practionor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
tehran TUMS complex
City
tehran
Province
Tehran
Postal code
1212232334
Phone
+98 21 8898 7667
Email
maleki.arayeh@gamil.com
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
data will be shared
When the data will become available and for how long
2019
To whom data/document is available
everybody
Under which criteria data/document could be used
no condition
From where data/document is obtainable
send an email:
maleki.arayeh@gmail.com
What processes are involved for a request to access data/document
Through an email explain your request and the reason for needing the data. in 2 weeks the data will be send.