The assessment of L-Lysine effect, as complementary treatment of chemical therapy, on biomarkers involved in patients with colorectal cancer and complications of chemical therapy
Conventional chemotherapy after surgery for colorectal cancer can lead to numerous complications. Due to the natural structure of the L-Lysine amino acid , it has no side effects and also has ability of completion conventional chemotherapy treatment for colorectal cancer. This study is a randomized, double-blind, placebo-controlled, single-center trial. Patients with colorectal cancer who are undergone surgery will be divided in 2 groups of intervention and control, 50 individuals in each group. Serum bio-markers will be evaluated at the base line and 3 months after the treatment due to investigation on probable effect of L-Lysine on decreasing bio-markers level in comparison with conventional therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010612020N1
Registration date:2013-03-13, 1391/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-13, 1391/12/23
Registrant information
Name
Hosein Mirmiranpour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2358
Email address
miranpour.h@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Colorectal Resaerch Center, Rasoulakaram Hospital,Tehran University of Medical Sciences
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of L-Lysine effect, as complementary treatment of chemical therapy, on biomarkers involved in patients with colorectal cancer and complications of chemical therapy
Public title
The effect of L-Lysine on biomarkers involved in colorectal cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age between 20 to 70 years; 2- The existence of colorectal cancer - Duke B; 3- The operation of colon after colorectal cancer; 4- The first time achieving chemical therapy after colorectal cancer surgery. Exclusion criteria: 1- No desire to continue the contribution in investigation during the study; 2- side effects of therapy.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab st.
City
Tehran
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
90-03-30-18863
Health conditions studied
1
Description of health condition studied
Colonl cancer
ICD-10 code
c18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Rectum cancer
ICD-10 code
c20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
ERCC1(Excision repair cross-complementing rodent repair deficiency, complementation group 1)
Timepoint
Baseline and 3 monhts following the end of treatment
Method of measurement
ELISA kit
2
Description
VEGF(Vascular endothelial growth facto)
Timepoint
Baseline and 3 monhts following the end of treatment
Method of measurement
ELISA kit
3
Description
DPD(Dihydropyrimidine dehydrogenase deficiency
Timepoint
Baseline and 3 monhts following the end of treatment
Method of measurement
ELISA kit
4
Description
TS(Thymidylate synthase)
Timepoint
Baseline and 3 monhts following the end of treatment
Method of measurement
ELISA kit
5
Description
CEA-Carcino Embryonic Antigen
Timepoint
Baseline and 3 monhts following the end of treatment
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
L-Lisyne powder 1.5g twice per day in combination with drugs of chemical therapy for patients in treatment group.
The duration of treatment with L-lysin is 3 month.
Category
Treatment - Drugs
2
Description
In control group : placebo is powder as the same shape and color as L-lysine in combination with chemotherapy drugs ,twice a day foe 3 month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoulakaram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
4th Floor, Centeral building of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Colorectal Resaerch Center, Rasoulakaram Hospital,Tehran University of Medical Sciences
Full name of responsible person
Hajar Nikbakht
Position
MD
Other areas of specialty/work
Street address
Colorectal Resaerch Center, Rasoulakaram Hospital, Sattarkhan
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2358
Fax
Email
hajarnik@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Resaerch Center, Rasoulakaram Hospital,Tehran University of Medical Sciences
Full name of responsible person
Hosein Mirmiranpour
Position
Assistant professor
Other areas of specialty/work
Street address
Colorectal Resaerch Center, Rasoulakaram Hospital, Sattarkhan
City
Tehran
Postal code
Phone
+98 21 6435 2358
Fax
Email
ddri.tums@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Colorectal Resaerch Center, Rasoulakaram Hospital,Tehran University of Medical Sciences
Full name of responsible person
Hajar Nikbakht
Position
MD
Other areas of specialty/work
Street address
Colorectal Resaerch Center, Rasoulakaram Hospital ,Sattarkhan
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2358
Fax
Email
hajarnik@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)