Determination of the effect of dalen mouthwash on incidence and treatment of stomatitis in patient undergoing chemotherapy
Design
Clinical trial with community-based and pragmatic control group with parallel binary blind groups, randomly blocked using six rows of four-row blocks with 22 individuals in each group.
Patients are hospitalized one day before chemotherapy and their mouth is evaluated after admission.
The solution used for the combined oral mucosal solution test group (drops of 12 nittine / 100 ml diphenhydramine syrup / and 250 ml of plum opioid 240 ml) was used in the placebo group (sterile water solution and a color similar to that of soluble solution Has a neutral effect). At day zero (one day before starting chemotherapy), the seventh day after chemotherapy and the 14th day after chemotherapy in the two groups of patients will be examined by a researcher and one assistant.
Settings and conduct
The research area is adult hematology and adult hematology located in Ahvaz Shafa Hospital.
Participants/Inclusion and exclusion criteria
* Inclusion criteria:
1.All patients with acute lymphoma and acute leukemia in the range of 18-68 years old who are referred to the Department of Advanced Hematology, Ahvaz Shafa Hospital, who get chemotherapy.
2. Have acute leukemia and lymphoma cancers under periodic chemotherapy.
3. When entering the study, there is no stomatitis.
* Exit criteria:
Radiation therapy is also associated with chemotherapy.
Intervention groups
Intervention in this study involves the use of a combined mouthwash
Dalen (Nystatin drops 12 ml / diphenhydramine syrup 100 ml / aluminum jig 240 ml) In the test group and using a sterile water solution and a colored substance(Similar to the color of the solution that has neutral effects)
In the placebo group.
Main outcome variables
Occurrence of stomatitis, Severity of stomatitis, recovery time.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037737N2
Registration date:2018-07-06, 1397/04/15
Registration timing:prospective
Last update:2018-07-06, 1397/04/15
Update count:0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
sedighe ghobadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 9717
Email address
ghobadian.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of the combined mouthwash (dalen) on treatment of stomatitis in patient undergoing chemotherapy
Public title
The effect of combined mouthwash on chemotherapy-induced ulcer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have acute leukemia and lymphoma cancers and are undergoing periodic chemotherapy.
When entering the study, there is no have stomatitis.
Exclusion criteria:
Having asthma and other allergic diseases
Radiation therapy is also associated with chemotherapy.
During the study, they develop a systemic infection.
Age
From 18 years old to 68 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Random Blocks (one per group):
Patients will be divided into two groups, the case (22 recipients of combined mouthwash) and control (22 patients taking placebo).
The division of selected subjects will be done randomly in blocks of study using quadrilateral blocks.
The division of selected subjects will be done in randomized blocks using six rows of four blocks (ABAB-BABA-ABBA-BAAB-AABB-BBAA). Combination mouthwash (A) and placebo group (B).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and the nurses caring the patients and the researchers did not know which groups were included in each group and which drug was used in each group, therefore, a double blind study will be conducted.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan. Ahvaz, IRAN.
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.AJUMS.REC.1396.722
Health conditions studied
1
Description of health condition studied
Palliative care
ICD-10 code
Z51.5
ICD-10 code description
Encounter for palliative care
Primary outcomes
1
Description
Occurrence of osteomathitis in patients undergoing chemotherapy
Timepoint
On day one, seventh and fourth sessions in two groups after intervention
Method of measurement
Nominal(was observedwas not observed)
2
Description
Severity of osteomathia in patients undergoing chemotherapy
Timepoint
On day one, seventh and fourth sessions in two groups after intervention
Method of measurement
There is no wound in the first degree. The second grade involves wound healing, but the person has the ability to eat.Grade 3 is large (more than 25% of the mouth level), and the individual has only the ability to eat the Maya.. In grade 4, hemorrhagic fever is bleeding and the patient is unable to receive the substance.
3
Description
Treatment time of osteomyte in patients undergoing chemotherapy
Timepoint
On day one, seventh and fourth sessions in two groups after intervention
Method of measurement
ased on the time of recovery symptoms of time-to-day
Secondary outcomes
1
Description
Gum wound healing
Timepoint
On day one, seventh and fourth sessions in two groups after intervention.
Method of measurement
prpportional
Intervention groups
1
Description
Intervention group: Intervention group: Using a combination of mouthwash (Dilute Nitatin 12 ml / Diphenhydramine 100 ml Syrup / Aloe Minim MJ 240 ml)
Category
Rehabilitation
2
Description
Control group: (A sterile water solution and a colored substance similar to that of a solution that has neutral effects) in identical glasses are given in appearance with a droplet
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Adult Hematology and Adult Hematology, Ahvaz , Shafa Hospital
Full name of responsible person
Neda Safikhani
Street address
Golestan.Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8621
Fax
+98 61 3373 8333
Email
Neda.moohamadzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Street address
golestan. Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8621
Fax
+98 61 3373 8333
Email
Elahi-n@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
50
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
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Assistant Professor, Faculty of Nursing and Midwifery, Ahwaz Jundishapur University of Medical Scien
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Deputy,School of Nursing and Midwifery. Academic town.Golestan Road.Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8621
Email
Elahi-n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tina vosoughi
Position
Assistant Professor. science Committee
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Ahvaz Golestan Road. Academic town. medical School. Domestic group.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Email
vosoughi-t@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Safikhani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
golestan.Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8621
Email
Neda.moohamadzadeh@yahoo.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data found in the related article will be presented.
When the data will become available and for how long
A year after the completion of the research project
To whom data/document is available
Applicants ,Students and professors
Under which criteria data/document could be used
Purchased an article from a printed magazine
From where data/document is obtainable
Magazine site
What processes are involved for a request to access data/document
Request a purchase, pay the desired amount of the magazine, access to the article