evaluate the efficacy of aqueous extract of Rheum ribes L. on FOLFOX-induced neuropathy in patients with Colorectal Cancer.
Design
This study is a randomized, double blind, placebo controlled trial conducte on 44 patients.
Settings and conduct
This study will be conducted multi centrally in Imam Khomeini Hospitals of Tehran, Shah Wali in Yazd, Yasrebi in Kashan and Baghiatallah of Qom
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Colorectal Cancer, aged between 20 and 80 years old, receiving the FOLFOX chemotherapy regimen
Exclusion criteria: patients with a history of other types of cancers, history of receiving chemotherapy, history of seizure and drug use anticonvulsants, previous neuropathy, having allergies and allergic to each of the components studied.
Intervention groups
The intervention group will be received required medications and 5 cc aqueous extract of rhubarb daily for seven days .This process continue until the seventh course of chemotherapy.
The intervention group will be received required medications and 5 cc placebo daily for seven days .This process continue until the seventh course of chemotherapy
Main outcome variables
the sensitivity touching cold
hyperalgesia
the severity of neuropathy
experiencing tingling in hands or feet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140817018828N4
Registration date:2018-06-02, 1397/03/12
Registration timing:retrospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
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
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
empty
Scientific title
Determination of Rheum ribes L. aqueous extract effect on FOLFOX-induced neuropathy in patients with Colorectal Cancer
Public title
Evaluation of Rheum ribes L. aqueous extract effect on neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Colorectal Cancer
aged between 20 and 80 years old
receiving the FOLFOX chemotherapy regimen
Exclusion criteria:
patients with a history of other types of cancers
history of receiving chemotherapy
history of seizure and drug use anticonvulsants
previous neuropathy
having allergies and allergic to each of the components studied
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Double blind
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind
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
City
Yazd
Province
Yazd
Postal code
8917693571
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.67
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
. Peripheral neuropathy
Timepoint
End of day 7 after each chemotherapy course until the seventh term of chemotherapy
Method of measurement
questionnaire
Secondary outcomes
1
Description
the sensitivity touching cold
Timepoint
End of day 7 after each chemotherapy course until the seventh term of chemotherapy
Method of measurement
questionnaire
2
Description
hyperalgesia
Timepoint
End of day 7 after each chemotherapy course until the seventh term of chemotherapy
Method of measurement
questionnaire
3
Description
experiencing tingling in hands or feet
Timepoint
End of day 7 after each chemotherapy course until the seventh term of chemotherapy
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patients randomly enter the intervention group, and use 5 ml of the prescribed extract for 7 days from the second day of chemotherapy until the seventh course of chemotherapy
Category
Treatment - Drugs
2
Description
Control group: Patients randomly enter the control group, and use 5 ml of the placebo for 7 days from the second day of chemotherapy until the seventh course of chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Fatemeh Ghotbinejad
Street address
Farmer Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Ghotbi_fat90@yahoo.com
2
Recruitment center
Name of recruitment center
Baghiatallah Hospital
Full name of responsible person
Fatemeh Ghotbinejad
Street address
Vanak Square
City
Qom
Province
Ghoum
Postal code
1435915371
Phone
+98 25 8805 0436
Email
Ghotbi_fat90@yahoo.com
3
Recruitment center
Name of recruitment center
Shah Vali hospital
Full name of responsible person
Fatemeh Ghotbinejad
Street address
Professor Hessabi Street
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3821 1091
Email
Ghotbi_fat90@yahoo.com
Web page address
4
Recruitment center
Name of recruitment center
Yasrebi Hospital
Full name of responsible person
Fatemeh Ghotbinejad
Street address
Ghotb-e- Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5562 1530
Email
Ghotbi_fat90@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
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
Alimohamad Ranjbar Jamal abadi
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 scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
Associate 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
Fatemeh Ghotbinejad
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Professor Hesabi Boolvar,
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Email
Ghotbi_fat90@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