Evaluate the effect of aqueous extract of Rheum ribes L. on the onset of ACT-induced nausea in patients with breast cancer
Design
Double-blind clinical trail
Settings and conduct
Yazd, Shah vali hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with breast cancer, aged range of 20-80 years, ACT chemotherapy regimen, complete patient satisfaction, and the first or second course of chemotherapy
exclusion criteria: patients with other cancer history, history of receiving chemotherapy, history of seizure and use of anticonvulsant drugs, nausea and vomiting degree 2 or 3 within 24 hours prior to chemotherapy, persistent, moderate or severe nausea, Hepatitis or gastrointestinal obstruction and metastasis
Intervention groups
The intervention group receives aqueous extract of Rheum ribes L. with anti-emetic medicines such as aprepitant and ondansetron. the control group receives placebo with anti-emetic medicines such as aprepitant and ondansetron.
Main outcome variables
Severity of nausea, duration of nausea, frequency of vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018828N6
Registration date:2018-06-27, 1397/04/06
Registration timing:retrospective
Last update:2018-06-27, 1397/04/06
Update count:0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
2016-08-29, 1395/06/08
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
empty
Scientific title
Investigating the anti-emetic effect of Rheum ribes L. aqueous extract on breast cancer patients receiving ACT chemotherapy
Public title
Investigating the anti-emetic effect of Rheum ribes L.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with breast cancer
Adriamycin, Cytoxan, Taxol (ACT) chemotherapy regimen
The first or second course of chemotherapy
Patient's satisfaction
Exclusion criteria:
Patients with other cancer history
History of receiving chemotherapy
History of seizure and use of anti-convulsant drugs
Nausea and vomiting degree 2 or 3 within 24 hours prior to chemotherapy
Persistent, moderate or severe nausea
Hepatitis or gastrointestinal obstruction and metastasis
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
56
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The numerical codes were drawn on the label of the extract and placebo glass based on the random numbers table prepared using the random block method
Blinding (investigator's opinion)
Double blinded
Blinding description
Extract and placebo was coded by a third person and patients; Statiscian; The author responsible for gathering data didnot aware of the content of the glasses, and their code was secretly kept until the end of the project.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Bahonar square, Yazd
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.68
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50-C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Severity of nausea
Timepoint
8 days after receiving chemotherapy
Method of measurement
National Chemotherapy Institute (NCI) table of nausea grade
Secondary outcomes
1
Description
Duration of nausea
Timepoint
8 days after chemotherapy
Method of measurement
How many days have nausea
2
Description
Frequency of vomiting
Timepoint
8 days after chemotherapy
Method of measurement
National Chemotherapy Institute (NCI) table of vomiting grade
Intervention groups
1
Description
Intervention group: aqueous extract of Rheum ribes L. , in 7 days, 5cc every day
Category
Treatment - Drugs
2
Description
Control group: placebo, in 7 days, 5cc every day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd, Shah vali hospital
Full name of responsible person
Seyede Negin Abrisham
Street address
Professor Hesabi Boulevard
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3821 1093
Email
negin.abrisham@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3724 0171
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Alimohammad RanjbarJamalabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boulevard, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3820 3865
Email
amranjbar@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohammad Ranjbar Jamalabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3820 3865
Email
amranjbar@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyede Negin Abrisham
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Jomhouri Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
8917944934
Phone
+98 35 3522 4310
Email
negin.abrisham@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