Oxaliplatin (OXL) is used in the treatment of colorectal cancer. Peripheral neuropathy is one of the most common dose-limiting toxicity of OXL which impair significantly the patients’ quality of life. Inflammatory cytokines induce inflammatory and neuropathic pain and hyper excitability by their direct and indirect effect on central and peripheral neurons and they are risk factors for the development of PN.Omega-3 fatty acids, eicosapentaenoic acid(EPA) and docosahexaenoic acid(DHA) have many beneficial effects in the psychiatric and neurodegenerative diseases and attenuated the production of pro inflammatory cytokines. The aim of this study is to evaluate the possible effects of omega-3 fatty acid supplementation on OXL-induced peripheral neuropathy (OXIPN) in patients with colon cancer. 60 patients with colon cancer candidate for receiving Oxaliplatin are being included in the study and those who are suffering from the diseases associated with neuropathy (e.g. diabetes and primary neural diseases); having history of previous chemotherapy and receiving any forms of supplementation (fish oil, vitamins &minerals) since 3 months before enrollment excluded from the study. They will be randomly assigned in a 1:1 ratio to receive oil fish pearls or placebo 3 times a day during the chemotherapy with oxaliplatin and one month after the end of the treatment. Incidence and severity of OXIPN (by TNSr) , Nerve conduction study (NCS) and serum levels of pro inflammatory cytokines, IL-1β, TNF-α and IL-6 and highly sensitive C reactive protein (hs-CRP), are assessed before treatment with oxaliplatin and at one month after the cessation of the treatment. To our knowledge, the evaluation of possible effects of omega-3 fatty acid supplementation on OXL-induced PN in patients with colon cancer was not studied before
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112158397N2
Registration date:2011-12-24, 1390/10/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-24, 1390/10/03
Registrant information
Name
Ali Esfahani
Name of organization / entity
Tabriz University of Medical Sciences, Hematology Oncology Reseach Center
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 1712
Email address
esfahania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Liver and Gastrointestinal Diseases Research Center,Tabriz University of Medical Sciences; IRAN Sanofi Aventis Group
Expected recruitment start date
2012-02-02, 1390/11/13
Expected recruitment end date
2013-08-02, 1392/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of omega-3 fatty acids on oxaliplatin-induced neuropathy and inflammation in patients with colon cancer
Public title
Omega-3 fatty acids and chemotherapy-induced neurotoxicity in colon cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: Patients with colorectal cancer (high risk stage 2, stage 3 & 4) candidate to receive oxaliplatin.
Exclusion criteria: Suffering from the diseases associated with neuropathy (e.g.diabetes, and primary neural diseases); any previous chemotherapy and receiving any forms of supplementation (fish oil, vitamins &minerals) since 3 months before enrollment
Age
From 20 years old to 85 years old
Gender
Both
Phase
3
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tabriz University of Medical Sciences
Street address
Research Deputy-Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-10-18, 1389/07/26
Ethics committee reference number
5/4/10130
Health conditions studied
1
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Incidence and severity of oxaliplatin-induced peripheral nauropathy
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
Reduced total neuropathy score(rTNS) and Electrophysiological evaluation
2
Description
Serum concentration of interleukin-1 beta
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
ELISA
3
Description
Serum concentration of interleukin-6
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
ELISA
4
Description
Serum concentration of TNF-alpha
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
ELISA
5
Description
Serum concentration of Highly sensitive-CRP
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
Nephlometry
Secondary outcomes
1
Description
concentrations of omega-3 fatty acids in the serum phospholipids
Timepoint
before chemotherapy with oxaliplatin and one month after the end of the treatment
Method of measurement
Gas chromatography
Intervention groups
1
Description
Intervention: Eligible recruited patients with colorectal cancer who randomly assigned to be in the intervention arm, received 640 mg oil fish pearls
(54% DHA and 10% EPA)3 times a day for 6 months during chemotherapy with oxaliplatin
Category
Treatment - Drugs
2
Description
Control: Eligible recruited patients with colorectal cancer who randomly assigned to be in the control arm received placebo pearls 3 times a day for 6 months(during chemotherapy with oxaliplatin)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhorais Clinic of Tabriz University of Medical Sciences
Full name of responsible person
Ali esfahani
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center,Tabriz University of Medical Sciences
Full name of responsible person
Mirinejad
Street address
Imam Khomeini Hospital, University Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Liver and Gastrointestinal Diseases Research Center,Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Added at 2014-08-27:SANOFI IRAN
Full name of responsible person
Added at 2014-08-27: Lida Zeinali
Street address
No 18, 35th, Alvand Ave., Argentina Square
City
Added at 2014-08-27: Tehran
Grant name
بروزرسانی 1393/6/5: -
Grant code / Reference number
Added at 2014-08-27: -
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Added at 2014-08-27:SANOFI IRAN
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Esfahani
Position
Hematologist-Oncologist, Assistant Professor of Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Ghazi Hospital of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 3811
Fax
Email
esfahania@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology-Oncology Research center,Tabriz University of Medical Sciences
Full name of responsible person
Ali Esfahani
Position
Hematologist-Oncologist, Assistant Professor of Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Shahid Ghazi Hospital, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1334 3811
Fax
Email
esfahania@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zohreh Ghoreishi
Position
Assistant professor of Nutrition Research Center, Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
zohreh_ghoreishy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)