Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470586
• Other study ID #: GH-1948-08
• Status: Completed
• Phase: N/A
• First received: November 5, 2011
• Last updated: November 10, 2011
• Start date: May 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: G. Hatzikosta General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.

Description:

Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with colorectal cancer

• Controls

Exclusion Criteria:

• ASA>3

• Metastatic Disease

• Acute bowel obstruction

• Acute bowel perforation

• BMI<30

• Chronic Systemic or Autoimmune Diseases

• Smokers

• Alcohol consumers

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Colon Rectal Resection
• Colorectal Cancer
• Colorectal Neoplasms
• Oxidative Stress

Intervention

Procedure:
• Surgery for colorectal cancer
Surgical resection of colorectal cancer

Locations

Country	Name	City	State
Greece	G. Hatzikosta General Hospital	Ioannina	Epirus

Sponsors (2)

Lead Sponsor	Collaborator
G. Hatzikosta General Hospital	University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Oxidative stress markers in patients with colorectal cancer and controls	Oxidative stress markers variation (8-PGF2a, Protein Carboyls, 3-Nitrotyrosine, 8-OHG) during and after surgery for colorectal cancer, and compare with controls	up to 2 years	No
Secondary	Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection	Validation of the responsiveness of markers of oxidative stress 8-PGF2a, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery	up to 2 years	No