A comparative study on the effect of sucking ice contained of pure water and ice contained of (mentha) mint extract on Xerostomia,nausea and vomiting during chemotherapy .
A comparative study on the effect of sucking ice contained of pure water and ice contained of (mentha) mint extract on Xerostomia,nausea and vomiting during chemotherapy
Design
This was a clinical trial. The participants consisted of 90 patients with breast cancer who convenient sampling was used and the selected individuals were randomly (lottery) assigned to control and intervention groups.
Settings and conduct
patients with breast cancer who visited the Emergency Oncology Ward of Omid Hospital at Mashhad for chemotherapy in 2016.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a gag reflex, being able to swallow, written informed consent;
Exclusion criteria: patients with kidney and digestive disease, restriction of fluid intake.
Intervention groups
Control group: Besides the routine treatment regimens, patients received 30 cc of water beginning from 5 minutes before the chemotherapy until the end. The first intervention group: Besides the routine treatment regimens, patients received 30 ice cubes, each containing 30 cc of water, provided in sterile packs beginning from 5 minutes before the chemotherapy until the end.
The second intervention group: Besides the routine treatment regimens, patients received 30 small ice cubes (1 cm2), each containing 30 cc of water plus one drop of mint, provided in sterile packs beginning from 5 minutes before the chemotherapy until the end.
Main outcome variables
Nausea, Vomiting, Xerostomia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160606028293N2
Registration date:2019-07-30, 1398/05/08
Registration timing:retrospective
Last update:2019-07-30, 1398/05/08
Update count:0
Registration date
2019-07-30, 1398/05/08
Registrant information
Name
mohammad haddadi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7241
Email address
haddadim92@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of sucking ice contained of pure water and ice contained of (mentha) mint extract on Xerostomia,nausea and vomiting during chemotherapy .
Public title
A comparative study on the effect of sucking ice contained of pure water and ice contained of (mentha) mint extract on Xerostomia,nausea and vomiting during chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer under chemotherapy
GAG reflex
Ability to swallow
Informed consent
Exclusion criteria:
Patients with gastrointestinal cancer
limitation in drinking
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
the selected individuals were randomly (lottery) assigned to control and intervention groups
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
sabzevar University of Medical Sciences
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618717653
Approval date
2015-07-15, 1394/04/24
Ethics committee reference number
IR.MEDSAB.REC.1394.53
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.8
ICD-10 code description
Overlapping lesion of breast
Primary outcomes
1
Description
Xerostomia
Timepoint
Before and After Chemotherapy
Method of measurement
VAS
2
Description
nausea
Timepoint
Before and After Chemotherapy
Method of measurement
vas
3
Description
vomiting
Timepoint
Before and After Chemotherapy
Method of measurement
Number
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Besides the routine treatment regimens, patients received 30 cc of water beginning from 5 minutes before the chemotherapy until the end.
Category
Treatment - Drugs
2
Description
The first intervention group: Besides the routine treatment regimens, patients received 30 ice cubes, each containing 30 cc of water, provided in sterile packs beginning from 5 minutes before the chemotherapy until the end.
Category
Treatment - Drugs
3
Description
The second intervention group: Besides the routine treatment regimens, patients received 30 small ice cubes (1 cm 1), each containing 30 cc of water plus one drop of mint, provided in sterile packs beginning from 5 minutes before the chemotherapy until the end.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Javad Ganjloo
Street address
Street koohsangi
City
Mashhad
Province
Razavi Khorasan
Postal code
9618717653
Email
haddadiM92@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research, Sabzevar University of Medical Sciences
Full name of responsible person
Javad Ganjloo
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618717653
Phone
+98 51 4464 7241
Email
haddadiM92@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618717653
Phone
+98 51 4464 7241
Fax
Email
m.haddadi96@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618717653
Phone
+98 51 4464 7241
Fax
Email
m.haddadi96@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Haddadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Building Number two,Vice Chancellor for Education,Sabzevar University of Medical Sciences and Health services
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618717653
Phone
+98 44647241
Fax
Email
m.haddadi96@gmail.com
Web page address
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