The aim of the this study is evaluating the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer .
Inclusion criteria was 18 to 75 years of age ; diagnosed with colorectal cancer ; scheduled to receive oxaliplatin-based regimens (FOLFOX 4) ; had more than 6 month life expectancy .
exclusion criteria was previous history of peripheral neuropathy ; symptomatic peripheral neuropathy at entry into the study ; received other chemotherapy regimens ; currently receiving anticoagulants ; platelet aggregation inhibitors ; opioids ; anticonvulsants ; tricyclic antidepressants ; previous history of hemorrhagic stroke .
Seventy patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens are enrolled in this study .
The sample size was calculated on the assumption α = 0.05 and power = 80%.
Enrolled patients were randomized into two groups (35/group ). First group received vitamin Eat a dose of 400 mg daily and second group observed , until after sixth course of the oxaliplatin regimen .
For oxaliplatin-induced peripheral neuropathy assessment , we used the symptom experience diary questionnaire .This questionnaire were completed at baseline, prior to each chemotherapy treatment, and after sixth course of chemotherapy completion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030621350N1
Registration date:2015-04-01, 1394/01/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-01, 1394/01/12
Registrant information
Name
Zeinab Salehi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7781 7995
Email address
zeinab_salehi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Isfahan university of medical sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2015-05-01, 1394/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin E onoxaliplatin-induced peripheral neuropathy prevention in coloractal cancer
Public title
Vitamin E in onoxaliplatin-induced neuropathy prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : 18 to 75 years of age ; diagnosed with colorectal cancer ; scheduled to receive oxaliplatin-based regimens (FOLFOX 4) ; had more than 6 month life expectancy
exclusion criteria : previous history of peripheral neuropathy ; symptomatic peripheral neuropathy at entry into the study ; received other chemotherapy regimens ; currently receiving anticoagulants ; platelet aggregation inhibitors ; opioids ; anticonvulsants ; tricyclic antidepressants ; previous history of hemorrhagic stroke
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jirib , Darvaze Shiraz
City
Isfahan
Postal code
Approval date
2014-04-13, 1393/01/24
Ethics committee reference number
293032
Health conditions studied
1
Description of health condition studied
cancer of colorectal
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
2
Description of health condition studied
pripheral neuropathy
ICD-10 code
G62.0
ICD-10 code description
Drug-induced polyneuropathy
Primary outcomes
1
Description
peripheral neuropathy
Timepoint
before study and then 3 months later
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
in intervention group :vitamin E 400 mg daily
Category
Prevention
2
Description
Control group were observed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Seyedoshohada Hospital
Full name of responsible person
Zeinab Salehi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan of University Medical Sciences
Full name of responsible person
Zeinab Salehi
Street address
Hezar Girib , Darvaze Shiraz
City
Isfahan
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 of Isfahan of University 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
Isfahan University of Medical Sciences
Full name of responsible person
Zeinab Salehi
Position
Resident
Other areas of specialty/work
Street address
Hezarjerib Street
City
Isfahan
Postal code
Phone
+98 912 490 8319
Fax
Email
zeinab_salehi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mahnaz Roayaei
Position
Assistant professor
Other areas of specialty/work
Street address
Hezarjerib Street
City
Isfahan
Postal code
Phone
+98 31 3792 2445
Fax
Email
Roayaei@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zeinab Salehi
Position
Resident
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
zeinab_salehi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)