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Insulin-Enhanced Nutrition for Colorectal Cancer

Phase 4

Waitlist Available

Led By Thomas Schricker, MD

Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years

Undergoing colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours after surgery

Awards & highlights

Study Summary

This trial will test whether adding insulin to current colorectal cancer surgery promotes making and keeping proteins in the body, and whether increasing the amount of protein given can further increase this effect.

Who is the study for?

This trial is for adults over 18 who are having surgery for non-metastatic colorectal cancer and can consent to participate. It's not for those with severe anemia, a BMI over 30, diabetes or high blood sugar levels, significant organ disease, muscle or nerve conditions, or a history that prevents epidural catheter use.Check my eligibility

What is being tested?

The study tests if insulin added after colorectal cancer surgery helps the body make and keep proteins when given with Travasol (an amino acid injection). The goal is to see if increasing protein intake boosts this effect while keeping blood sugar normal.See study design

What are the potential side effects?

Possible side effects may include low blood sugar due to insulin therapy. There might also be reactions at the injection site from Travasol or insulin. Other general risks could involve changes in metabolism affecting glucose and lipid levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am having surgery for early-stage colon cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Net protein balance

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Insulin, Travasol (35%) postopExperimental Treatment2 Interventions

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .

Group II: Insulin, Travasol (20%) postopExperimental Treatment2 Interventions

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.

Group III: Insulin, no protein after surgeryPlacebo Group1 Intervention

Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Insulin human

FDA approved

0 / 2Eligibility criteria met