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Effect of Peppermint (Mentha piperita) on Nausea, Vomiting and Anorexia in pediatrics with leukemia Undergoing Chemotherapy: A Randomized Controlled Trial

Protocol summary

Study aim
The effect of mint on nausea, vomiting and anorexia in children with leukemia
Design
Study is a randomized clinical trial that will be performed on two groups of patients (control and intervention). Phase 3 is study that will be performed on 68 patients. Rand function in Excel software will also be used.
Settings and conduct
The study is a randomized clinical trial in quadruple blocks in which the collector and statistical expert are not aware of how to blind the samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria: written consent to participate in the study, definitive diagnosis of myeloid leukemia and acute lymphocytic (other than None M3ALL), receiving chemotherapy, history) Receive at least one course of chemotherapy, history of nausea experience following previous chemotherapy sessions ,, Age 3 to 18 years No entry conditions :nausea and vomiting resistant to treatment, severe gastrointestinal problems, other nausea problems such as hypertension, liver failure, kidney, concomitant radiotherapy with chemotherapy, allergy to mint
Intervention groups
The number of vomits in the day before chemotherapy in the intervention group and the control group are examined. In the intervention group, in addition to routine anti-nausea treatments, 12 hours before chemotherapy and up to 48 hours after, 1 drop in weight every 8 hours, peppermint extract (Super Mate drops) with 20 cc Urban tap water is given to patients The control group, they receive only routine anti-nausea drugs.
Main outcome variables
Nausea, vomiting, anorexia, leukemia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171203037733N4
Registration date: 2021-12-15, 1400/09/24
Registration timing: prospective

Last update: 2021-12-15, 1400/09/24
Update count: 0
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Mehran Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.akbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Peppermint (Mentha piperita) on Nausea, Vomiting and Anorexia in pediatrics with leukemia Undergoing Chemotherapy: A Randomized Controlled Trial
Public title
Effect of pippermint on nausea in pediatrics with leukemia undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written conset to participate in the study Definitive diagnosis of myeloid leukemia and acute lymphocytic (ALL and AML) by a pediatric hematologist and oncologist (other than None M3ALL ) Receiving chemotherapy courses History of receiving at least one course of chemotherapy Experience of nausea following previous chemotherapy sessions No concomitant radiotherapy with chemotherapy Age 3 to 18 years
Exclusion criteria:
Using medications or other treatments to reduce nausea other than the usual prescribed anti-nausea and vomiting medications (especially herbal remedies) Nausea and vomiting resistant to treatment Unwillingness to participating in the study sensitivity to mint other nausea problems such as hypertention , liver failure , kidney and digestive problems
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are available from among children with acute myeloid leukemia and lymphocytosis undergoing chemotherapy. The samples are then assigned to two random groups as random quadruple blocks A, A, B, and B.It should be noted that the Rand function in Excel software will be used for randomization. The statistician and the sample collector are not aware of how the samples are blinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The statistician will do the randomization, one of the colleagues will do the sampling plan, and the treating physician will assign the patients to the groups. The statistician and the sample collector are not aware of how the samples are blinded.
Placebo
Not 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
Arak Univerity of Medical Sciences, Payambar aazam, University Complex, Basij SQ, Sardasht region
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2021-11-08, 1400/08/17
Ethics committee reference number
IR.ARAKMU.REC.1400.211

Health conditions studied

1

Description of health condition studied
Nausea, vomiting and Anorexia
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea
Timepoint
Before, immediately, 24 hours, 48 hours after chemotherapy
Method of measurement
VAS questionnaire and measurement table and Face scale

2

Description
Vomiting
Timepoint
Before, immediately, 24 hours, 48 hours after chemotherapy
Method of measurement
VAS questionnaire and measurement table and Face scale

3

Description
Anorexia
Timepoint
Before, immediately, 24 hours, 48 hours after chemotherapy
Method of measurement
VAS questionnaire and measurement table and Face scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The samples are assigned to two random groups as quadruple random blocks A, A, B, and B. First, written and informed consent was obtained from the patients. Then, with the help of VAS visual scale, the amount of nausea and anorexia and with the help of frequency table, the number of vomiting cases in the day before chemotherapy in the intervention and control groups are examined. In the intervention group, in addition to routine anti-nausea treatments, 12 hours before chemotherapy and up to 48 hours after, 1 drop in weight (1 Drop per kilogram) every 8 hours, peppermint extract (Super Mate drops) (Barij Essence Pharmaceutical Company) with 20 cc Urban tap water is given to patients (measurement of nausea, vomiting and anorexia half an hour before chemotherapy, immediately, 24 and 48 hours after chemotherapy) .All medications taken are recorded by the sample collector.
Category
Treatment - Drugs

2

Description
Control group: In the control group, they receive only routine anti-nausea drugs and their nausea, vomiting and anorexia are measured by VAS scale half an hour before chemotherapy, immediately, 24 and 48 hours after re-chemotherapy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ward of Pediatric Blood and Oncology, Amirkabir Hospital of Arak city,
Full name of responsible person
Mehran Akbari
Street address
Railway Street, Amir Kabir Educational and Medical Center, Arak, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 4715
Email
mehranakbari1373@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Post code: 3848176341 Basij Square, Sardasht region, Deputy of research and technology, Payambar Aazam University Complex، Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
mehranakbari1373@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
Khomein University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Postal Code: 38817-43364, Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran Ahbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Postcode: 38818-43364, Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.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
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