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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
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
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
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable