Comparison of the effect of sodium bicarbonate and zinc chloride mouthwashes on treatment of oral mucositis in patients with cancer under chemotherapy in Hamadan Imam Khomeini clinic, 2019
Comparison of the effect of sodium bicarbonate and zinc chloride mouthwashes on treatment of oral mucositis in patients with cancer under chemotherapy
Design
Clinical trial with two intervention groups and one control group with parallel, two-way blind groups, randomized
Settings and conduct
This study will be performed blindly in Imam Khomeini Clinic of Hamedan, the participants as well as the person who will analyze the data will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-65 years with stage 1 and 2 cancer who are undergoing chemotherapy and do not have oral ulcers and are not allergic to sodium bicarbonate and zinc chloride and have normal platelet and white blood cell levels.
Inclusion criteria: Absence at least one session in the treatment or follow-up phase and hypersensitivity to zinc chloride and sodium bicarbonate, as well as the patient's disability and excessive weakness
Intervention groups
Patients in all three groups will be included in the study from the first day of chemotherapy for 14 days.
All patients participating in research will be trained on routine care (teeth brushing, proper nutrition, non-smoking, and tooth health checkup)
The intervention group (A) receives 2 times every 8 hours and each time 10 cc 10% sodium bicarbonate solution.
The intervention group (B) receives 2 times every 8 hours and each time 10% sulfate solution.
The control group (placebo) receives 2 times every 8 hours and each time 10 cc sterilized water solution. Patients will rinse for 2 minutes in all three groups.
The time interval between two series of mouthwashes is set to 15 minutes.
Main outcome variables
treatment of oral mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N3
Registration date:2020-11-26, 1399/09/06
Registration timing:registered_while_recruiting
Last update:2020-11-26, 1399/09/06
Update count:0
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sodium bicarbonate and zinc chloride mouthwashes on treatment of oral mucositis in patients with cancer under chemotherapy in Hamadan Imam Khomeini clinic, 2019
Public title
The effect of mouthwash on the treatment of oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients with cancer aged 18-65 years
• Stage I and II of Cancer
• Under chemotherapy
• With no oral ulcer
• To be able to carry out a mouthwash
• Having a normal level of white blood cells and platelets
• Not using another medication to prevent and treat oral mucositis
• Not being in pregnancy and lactation time
• Not receiving chemotherapy and radiotherapy simultaneously
• No other physical and mental disorders
• Insensitivity to zinc chloride and sodium bicarbonate
• Receiving at least one drug from the category of commonly used chemotherapy drugs
• Not receiving chemotherapy drugs which increase mucositis, such as actinomycin and ...
Exclusion criteria:
• Absence in at least one session of determined days for treatment follow-up
• Hypersensitivity to zinc chloride and sodium bicarbonate
• Extensive disability and weakness of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the participants to the zinc chloride, sodium bicarbonate and control groups, write the names of the three groups on a piece of paper and remove them randomly and the order of sampling of the groups will be determined.For random allocation of samples in three groups, 20 blocks of 6 will be used as random block allocation. Thus, the letter A will be considered for the zinc chloride group, the letter B for the sodium bicarbonate group and the letter C for the control group.On pieces of paper, and we will come across randomly. Sampling will then begin according to the possible order.
Blinding (investigator's opinion)
Double blinded
Blinding description
In which patients will be blind about their allocation in intervention groups. In addition, the person who will analyze the data will be blind about the allocation of people in the groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Hamedan University of Medical Sciences
Street address
Beginning of Khajeh Rashid Blvd, Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838698
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.UMSHA.REC.1399.651
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
D01
ICD-10 code description
Carcinoma in situ of other and unspecified digestive organs
Primary outcomes
1
Description
Treatment of oral mucositis
Timepoint
1 day before the intervention and 1, 4, 7 and 14 days after the intervention
Method of measurement
Visual Analogue Scale, Oral mucositis index, World Health Organization criteria for grading of oral mucositis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group (A)Receives 10% zinc chloride solution 2 times every 8 hours and 10 cc each time.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes.
Category
Treatment - Drugs
2
Description
Intervention group:Intervention group (B) receives 10% sodium bicarbonate solution every 8 hours 2 times. Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes.
Category
Treatment - Drugs
3
Description
Control group:The control group (placebo) receives 10 cc of sterile water solution twice every 8 hours.Patients rinse for 2 minutes.The time interval between the two series of mouthwashes is set to 15 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini Clinic
Full name of responsible person
Ramesh Kamalan
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
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
Saeid Bashirian
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
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
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
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
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
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