Comparison the effect of sodium bicarbonate and zinc chloride mouth washes on incidence and severity of oral mucositis in patients with cancer under chemotherapy
Comparison the effect of sodium bicarbonate and zinc chloride mouthwashes on incidence and severity of oral mucositis in patients with cancer under chemotherapy
Design
A randomized clinical trial with a control group, with three parallel groups
Settings and conduct
The present study is a three-group clinical trial that will be performed on 144 cancer patients in Hamedan in 1398. Patients will be randomly divided into three groups (two intervention and one control group). In intervention groups patients will receive sodium bicarbonate solution and zinc chloride solutions and control group will receive placebo. People in each of the three groups will rinse for 2 minutes. The interval between two mouthwashes is set at 15 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with cancer aged 18 to 65 years, cancer stage 1 or 2 , Absence of oral ulcers, No sensitivity to zinc chloride and sodium bicarbonate .Exclusion criteria: unwillingness to continue participating in the study, Absence on at least one day of follow-up.
Intervention groups
Intervention group (A): Patients will receive 5% sodium bicarbonate solution every eight hours twice. Intervention group (B): Patients will receive 0.5% zinc chloride solution every eight hours twice. Control group (placebo) receive 2 cc placebo(destilled water) every eight hours twice. People in each of the three groups will rinse for 2 minutes. The interval between two mouthwashes is set at 15 minutes.
Main outcome variables
Incidence and severity of oral mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N28
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of sodium bicarbonate and zinc chloride mouth washes on incidence and severity of oral mucositis in patients with cancer under chemotherapy
Public title
Comparison the effect of sodium bicarbonate and zinc chloride mouth washes on incidence and severity of oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer aged 18 to 65 years
Cancer stage 1 or 2
Absence of oral ulcers
No sensitivity to zinc chloride and sodium bicarbonate
Exclusion criteria:
Absence on at least one day from the days designated for follow-up
Dissatisfaction with continuing to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of samples in three groups, 6 blocks will be used as random block allocation. For this purpose, 20 modes of 6-block are written on pieces of paper and put in envelopes and randomly replaced. Patients will be assigned to the intervention or control groups according to the order of the letters of the blocks removed.
Blinding (investigator's opinion)
Not 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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.UMSHA.REC.1398.335
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Incidence and severity of oral mucositis
Timepoint
Before and up to twenty days after the intervention
Method of measurement
World Health Organization Mucositis Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(1): patients receive 5% sodium bicarbonate solution every 8 hours, 2 times for 21 days.
Category
N/A
2
Description
Intervention group(2): patients will receive 0.5% zinc chloride solution every 8 hours, 2 times for 21 days.
Category
N/A
3
Description
Control group(placebo): patients will receive 2 cc placebo (distilled water) every 8 hours, 2 time for 21 days.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Fatemeh Mohamadi
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
f.Mohammadi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Mohamadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
f.Mohammadi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Mohamadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
f.Mohammadi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ramesh Kamalan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
rameshkamalan98@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available