This study will be performed as a double-blind, placebo-controlled clinical trial in Baghban Clinic of Mazandaran University of Medical Sciences on 60 patients with chemotherapy-induced nausea and vomiting. The patients experienced nausea and vomiting during the previous cycle of chemotherapy who received the same chemotherapy regime with previous chemotherapy cycle will be randomly enrolled in 3 groups containing of 20 patients to receive placebo, apple or barberry syrup. Due to the four-digit code for each syrup, patients in each group and their physicians will not be aware of the type of treatment which they will receive and the patients also will receive routine anti-emetic treatments along with the study drug. The objectives of the study is to reduce the chemotherapy-induced nausea and vomiting. The efficacy of the interventions on incidence and severity of nausea and vomiting will be recorded in the data collection form based on MASCC/ESMO Antiemetic Guidelines and compared with the appropriate statistical tests by SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709142027N10
Registration date:2017-09-27, 1396/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of apple (Malus domestica) syrup and barberry (Berberis orietalis) syrup on chemotherapy-induced nausea and vomiting
Public title
study of the effects of apple syrup and barberry syrup on chemotherapy-induced nausea and vomiting
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patients older than 18 years; with diagnosed cancer that experienced nausea and vomiting during the previous cycle of chemotherapy who received the same chemotherapy and anti-emetic regime with previous chemotherapy cycle at the time of enrollment in the study
Exclusion criteria: Uncontrolled Diabetes Mellitus; Changes in chemotherapy regime; Having other clinical conditions that cause nausea and vomiting such as brain metastasis.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The eligible patients will be assigned to the treatments (apple and barberry syrup) or placebo groups by simple randomization as 1:1:1 ratio
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of mazandaran University of Medical Sciences
Street address
Moallem Square, Research Deputy of Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2017-04-04, 1396/01/15
Ethics committee reference number
IR.MAZUMS.REC.95.2254
Health conditions studied
1
Description of health condition studied
chemotherapy-induced nausea and vomiting
ICD-10 code
Y43.3
ICD-10 code description
Drugs, medicaments and biological substances causing adverse effects in therapeutic use
Primary outcomes
1
Description
Incidence of nausea
Timepoint
24 hours after chemotherapy
Method of measurement
Patients questionnaire based on MASCC/ESMO Antiemetic Guidelines
2
Description
Incidence of vomiting
Timepoint
24 hours after chemotherapy
Method of measurement
Patients questionnaire based on MASCC/ESMO Antiemetic Guidelines
Secondary outcomes
1
Description
Severity of nausea
Timepoint
1 day before chemotherapy to 6 days after chemotherapy
Method of measurement
Patients questionnaire based on MASCC/ESMO Antiemetic Guidelines
2
Description
Severity of vomiting
Timepoint
1 day before chemotherapy to 6 days after chemotherapy
Method of measurement
Patients questionnaire based on MASCC/ESMO Antiemetic Guidelines
Intervention groups
1
Description
barberry syrup 34.75%
1 day before chemotherapy to 6 days after chemotherapy, 10 ml of syrup Three times daily
Category
Treatment - Drugs
2
Description
Apple syrup 20%
1 day before chemotherapy to 6 days after chemotherapy, 10 ml of syrupTDS daily
Category
Treatment - Drugs
3
Description
Placebo syrup
1 day before chemotherapy to 6 days after chemotherapy, 10 ml of syrupTDS daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Clinic of Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Street address
Khazar Square
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice Chancellor for Research, Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar squar
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Khazar Square
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)