Determine effect of Peppermint on nausea, vomiting and anorexia in Patients with breast cancer under chemotherapy
Design
Controlled clinical trial with a parallel group design
Settings and conduct
This study will be carried out at Ayatullah Khansari Hospital in Arak. Samples will be selected from female patients with breast cancer under chemotherapy..
Participants/Inclusion and exclusion criteria
The inclusion criteria included: diagnosis of breast cancer breast cancer and satisfaction participate in the study. Exclusion criteria included: discontinuation from the study and allergic to peppermint.
Intervention groups
Group 1 (intervention): 40 drops of Peppermint every 8 hours plus 20 cc of water; 12 hours before and 48 hours after chemotherapy
Group 2 (placebo): 40 drops of distilled water every 8 hours plus 20 cc of water; 12 hours before and 48 hours after chemotherapy
Main outcome variables
Nausea; Vomiting; Anorexia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130731014229N7
Registration date:2018-04-19, 1397/01/30
Registration timing:prospective
Last update:2018-04-19, 1397/01/30
Update count:0
Registration date
2018-04-19, 1397/01/30
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Peppermint (Mentha Piperita) with placebo on nausea, vomiting and anorexia in patients with breast cancer under chemotherapy
Public title
Effect of Peppermint on nausea, vomiting and anorexia in patients with breast cancer under chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Diagnosis of breast cancer
History of receiving a chemotherapy course
Experience nausea following previous chemotherapy
Exclusion criteria:
Unwillingness to continue participating in the study
Forgetting the use of Peppermint in three times
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to quadruple blocks A, A, B, B in random groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer do not know which groups are located. The samples in the intervention and control group did not know whether they received the placebo or the main drug. The statistician will receive questionnaires as anonymously and in form A and B, and he does not know which are intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.ARAKMU.REC.1396
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
At the beginning of the study (before the intervention) and immediately, 24 and 48 hours after the end of the chemotherapy
Method of measurement
VAS scale
2
Description
Vomiting
Timepoint
At the beginning of the study (before the intervention) and immediately, 24 and 48 hours after the end of the chemotherapy
Method of measurement
Frequency table
3
Description
Anorexia
Timepoint
At the beginning of the study (before the intervention) and immediately, 24 and 48 hours after the end of the chemotherapy
Method of measurement
VAS Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, in addition to the medications prescribed by the physician, will be given 40 drops of peppermint of Barij Essence Company plus 20 cc of water every 8 hours, 12 hours before and 48 hours after the Chemotherapy,
Category
Prevention
2
Description
Control group: For control group will be used normal saline as a placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital
Full name of responsible person
Hadi Jafarianesh
Street address
Daneshgah Ave.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad ََArjomandzadegan
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD