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Ethics committees
#1
2019-05-21, 1398/02/31
2019-12-17, 1398/09/26
2019-0512-2117 00:00:00
IR.SEMUMS.REC.1398.054
IR.SEMUMS.REC.1398.212
IR.SEMUMS.REC.1398.054IR.SEMUMS.REC.1398.212
Protocol summary
Study aim
Comparison the effect of zingiber and acupressure on chemotherapy
induced nausea and vomiting patients with breast cancer
Design
Controlled randomized clinical trial, with parallel groups, without
blindness.
Settings and conduct
This is a randomized controlled clinical trial study in which four groups
of Zingiberr, placebo of Zingiber, acupressure and placebo-acupressure will
be done on 80 patients with breast cancer undergoing chemotherapy
referring to hospitals affiliated to Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definite diagnosis of breast cancer; existing at least three cycles of chemotherapy. Exclusion criteria: Sensitivity to Zingiber; history of any abnormal hemorrhage; use of blood diluent drugs; coagulation disorders
Intervention groups
1) Zingiber group (receiving 500 mg of Vomigone tablets) 2) Zingiber
placebo group (receiving placebo tablets similar to Vomigone tablets) 3)
Acupressure intervention group (use of acupressure wristband at the point
of neiguan or P6) 4) Acupressure placebo group (Use acupressure
wrisbands in opposite site of the neiguan point)
Main outcome variables
Nausea and Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N10
Registration date:2019-11-24, 1398/09/03
Registration timing:prospective
Last update:2019-12-21, 1398/09/30
Update count:1
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of zingiber and acupressure onchemotherapy induced nausea and vomiting (CINV) in patients with breast cancer
Public title
Comparison of the effect of zingiber and acupressure on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of breast cancer by an oncologist and pathologist
Age between 18 and 70 years
The normal values of hematological and biochemical laboratory values in the Zingiber group
The desire to participate in the study
Exclusion criteria:
Sensitivity to Zingiber and its consumption over the past week (at first use)
The presence of sensitivity and ulcers or any skin problems at the site of use of acupressure wristband
Use of blood diluent such as Aspirin, Warfarin, Heparin, Plavix and ... in the Zingiber group.
Coagulation disorders (platelets less than 100,000/mm3, etc.) in the Zingiber group
Receiving radiotherapy and chemotherapy simultaneously
The diseases that lead to nausea and vomiting include liver, kidney, upper gastrointestinal cancer, acute hepatitis B, gastrointestinal obstruction, brain malignancies, high blood pressure, motion sickness, diabetes and electrolyte disorders such as hyponatremia and Hypokalemia
Use of alcohol and opium
The history of psychiatric problems in patients under treatment with acupressure wristband
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to four groups (zingiber, acupressure, zingiber
placebo and placebo of acupressure) will be done randomly using random
blocks method. 10 blocks with 8 cases in each are created and every time
randomly a block will be selected. In this method, A: represent zingiber
group; B: acupressure; C: zingiber placebo; D: placebo of acupressure (false point).
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
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences (SEMUMS), Vice Chancellor of Research and Technology , Bassij Blvd., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.SEMUMS.REC.1398.212
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified
Primary outcomes
1
Description
severity of nausea and vomiting
Timepoint
Evaluation and measurements will be performed from the first day of chemotherapy up to 5 days after the completion of chemotherapy by the patient.
Method of measurement
Morrow Assessment of Nausea and Emesis (MANE)
2
Description
frequency of nausea and vomiting
Timepoint
Evaluation and measurements will be performed from the first day of chemotherapy up to 5 days after the completion of chemotherapy by the patient.
Method of measurement
Morrow Assessment of Nausea and Emesis (MANE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All participants in Zingiber intervention group, after assuring the results of the tests, in addition to the routine interventions prescribed by the physician, receive Vomigone pills (500 mg) Produced by Dineh Pharmaceutical Company for the first day of chemotherapy, half an hour before the injection of chemotherapy drugs, and the next time, at 9 o'clock of the same day. Continue taking tablets twice a day at 9 am and 9 pm, 5 days after the completion of chemotherapy. If the patient is raised, within two hours, the drug will be re-used.
Category
Prevention
2
Description
Intervention group: In the acupressure intervention group, in addition to the routine interventions prescribed by the physician, the acupressure wristbands will be closed in two hands for half an hour before starting the injection of drugs up to 5 days after the completion of chemotherapy in the neiguan (P6) point.
Category
Prevention
3
Description
Control group: In the Zingiber placebo group, placebo tablets similar to Vomigone tablets (size, shape, color, taste and dosage but lacking the active ingredient) will be used. The method is similar to the Zingiber group.
Category
Placebo
4
Description
Control group: In the acupressure placebo group, the wristbands will close on both sides of the arm on the wrist with a plastic point at the opposite point of the neiguan point (false point). The method of doing is similar to the acupressure group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated to Tehran University of Medical Sciences including Amir Aalam
Full name of responsible person
Hassan Babamohamadi
Street address
Enghelab Street - at the beginning of north Sadi Street.
City
Tehran
Province
Tehran
Postal code
3513138111
Phone
+98 21 6670 6106
Email
hamiralam@sina.tums.ac.ir
Web page address
http://amiralam.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Seman
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.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
Not applicable
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