The goal of this randomized clinical trial is the evaluation of effect of propolis tablet on prevention and treatment of chemotherapy induced oral mucositis. This is a randomized double-blind and placebo-control study. Fifty patients with colon cancer and under the Folfox chemotherapy regimen who are referred to Imam Khomeini hospital in Sari are randomly placed in 2 groups of 25 people (intervention and control group). The first group of patients receive 2 propolis tablets daily up to 21 days (Tab 50mg).The second group receive placebo. All patients are visited at first and then every week until 3 weeks by oral diseases speciallist and oral mucositis is recorded according to WHO and OMAS indices.
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT2017060933722N2
Registration date:2017-07-02, 1396/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Tahereh Molania
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3861
Email address
tmolania@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of propolis tablets on chemotherapy induced oral mucositis
Public title
Evaluating the effect of propolis tablets on chemotherapy induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with colon cancer who receive Folfox chemotherapy regimen with oral mucositis at grade 0 level from WHO indice.
Exclusion criteria: Chronic liver failure(stage2,3); Chronic kidney disease(stage4,5); Oral signs and symptoms of any type of allergy and sensitivity to honey and propolis.
Age
From 18 years old to 75 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of random number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran Universiyy Of Medical Sciences
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
City
Sari
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.MAZUMS.REC.96.2995
Health conditions studied
1
Description of health condition studied
chemotherapy induced oral mucositis
ICD-10 code
k12.3
ICD-10 code description
oral mucositis ( drug induced )
Primary outcomes
1
Description
Severity of oral mucositis
Timepoint
once a week (weekly )
Method of measurement
according to WHO and OMAS indices
Secondary outcomes
1
Description
_
Timepoint
_
Method of measurement
_
Intervention groups
1
Description
Intervention group: administration of oral propolis tablet 50mg,twice a day(BID) up to 21 days.
Category
Treatment - Drugs
2
Description
Control group: receives pelacebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parisa Ghodrati
Street address
Amirmazandarani street, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran university of medical sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
City
Sari
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, Mazandaran university of medical sciences