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Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial

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ClinicalTrials.gov Identifier: NCT02746432
Recruitment Status : Not yet recruiting
First Posted : April 21, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Mazen Hassanain, King Saud University

Study Description
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Brief Summary:

Research Problem:

Surgical stress induces inflammation and postoperative immuno-suppression, which are risk.

factors for both post-operative complication and possible disease recurrence. Colorectal cancer is in the top 5 malignancies in the Kingdome and the highest incidence in males. Recurrent disease locally or distally occurs in 35% of patients and is the leading cause of death in these patients. Despite the new era of laparoscopic surgery, still surgical stress is present and equally traumatic to the conventional open colorectal resection, earlier studies showed no major differences in post-operative inflammatory and immunological reactions. The previous studies revealed the anti-inflammatory effects of the hyper-insulinimic euglycemic therapy. Benefits observed in both major liver resection and in cardiac surgery. The anti-inflammatory effect reduced the surgical stress and postoperative inflammation.

The hypothesis is "Can intraoperative hyper-insulinimic euglycemic infusion reduce post operative inflammation and immunomodulation in colon cancer patients undergoing a curative surgery?"

Research methodology Triple blinded randomized controlled study with estimated sample size of 144 patients of non-metastatic colorectal cancer patients operated at King Saud University Medical city with a confirmed diagnosis of colon adenocarcinoma. Patients Consented will undergo computer randomization to receive intraoperative hyper-insulinimic normoglycemic infusion (experimental) or standardized insulin sliding scale and saline (control). A common preoperative and postoperative pathway with standardized management and pain control in both groups.

Outcomes will be measured via a battery of laboratory test consist of routine labs, inflammatory markers and immunological markers to be repeated at fixed timed intervals. All patients will be followed by regularly for 5 years.

Research objectives

Primary outcomes to examine:

  • The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery.
  • The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion

Secondary outcomes:

  • Thirty days post-operative morbidity.
  • Overall survival rate.
  • Disease-free survival rate.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Hyper insulinemic euglycemic clamp Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Insulin Therapy Reduce Post-Operative Inflammatory Response After Curative Colorectal Cancer Resection: Randomization Controlled Trial
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Routine intra operative saline infusion to be administered.pre-operation and timed assessment lab set to be obtained.
Experimental: Intervention group.Hyper insulinemic euglycemic clamp
After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin (Human regular insulin) ) infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained.
 Drug: Hyper insulinemic euglycemic clamp
After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin (Human regular insulin) to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained.


Outcome Measures
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Primary Outcome Measures :
  1. The anti-inflammatory effects of intraoperative hyper-insulinimic euglycemic therapy in patients undergoing colorectal cancer surgery. [ Time Frame: 1 month ]
    effect on Inflamatory profile namely levels of Tnf- Alpha , IL-8 , IL-6 , IL-10 , IL-1B,IL-18 , IFNγ, MIp1-Alpha , MMP-8 , TGF Beta , CRP


Secondary Outcome Measures :
  1. The immunomodulatory effect of intraoperative hyper-insulinimic euglycemic infusion. [ Time Frame: 1 month ]
    Change of CD4 , CD8 & T-cell , Quantity and activity


Other Outcome Measures:
  1. Thirty days post-operative morbidity [ Time Frame: 30 days ]
  2. Overall survival rate [ Time Frame: 5 years ]
  3. Disease-free survival rate [ Time Frame: 5 years ]
  4. Thirty days post-operative mortality [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Documented CRC by histopathology

Exclusion Criteria:

  • Patient not consenting to the study or refused.
  • Metastatic disease at the time of diagnosis.
  • Contraindications to insulin
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746432


Contacts
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Contact: Faisal A Al-Alem, MBBS SBGS 00966506238992 faisal.alalem@gmail.com
Contact: Mazen M Hassanain, MBBS FRCSC FACS PhD +966 50 514 1090 mhassanain@ksu.edu.sa

Locations
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Saudi Arabia
King Saud University Medical City Recruiting
Riyadh, Saudi Arabia, 7805
Contact: Weam S Husseim    +966541480459    wshussain@ksu.edu.sa   
Contact: Sara Aloudah    +96654602288    oudahsara@gmail.com   
Principal Investigator: Dr. Mazen M Hassanain, MBBS FRCSC FACS PhD         
Sub-Investigator: Dr. Ahmad M Zubaidi, MBBS MSc FRCSc         
Sub-Investigator: Dr. Khayal A Al-Khayal, MBBS FRCSC         
Sub-Investigator: Dr. Faisal A Alalem, MBBS SBGS         
Sponsors and Collaborators
King Saud University
More Information
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Publications:

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Responsible Party: Mazen Hassanain, Assistant Professor & Counsultant HPB and transplant Surgeon, King Saud University
ClinicalTrials.gov Identifier: NCT02746432     History of Changes
Other Study ID Numbers: KSULDRCCRCMH001
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mazen Hassanain, King Saud University:
CRC-Insulin
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs