Colon Carcinoma Clinical Trial
Official title:
Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients
Rationale: It is well known that insulin resistance occurs after mediocre and intensive
surgery, such as colon cancer surgery. Disturbances in insulin action negatively affect the
postoperative recovery, either by prolonging the capacity of the body to regain normal
function, or by increasing the metabolic stress and the risk for complications. Several
studies have shown that focusing therapies on improving insulin resistance is successful.
Experimental studies have shown that antioxidant agents, like glutamine (a precursor of
glutathione), improve insulin sensitivity. The hypothesis of this study is that
perioperative parenteral or enteral administration of glutamine, given as the dipeptide
alanyl-glutamine, will reduce or prevent postoperative insulin resistance in colon cancer
patients. The study will also be focused on the different routes of administration, because
of the expected differential metabolic effects.
Objective: The investigators' primary objective is to study whether intravenous or enteral
administration of the dipeptide alanyl-glutamine will reduce or prevent postoperative
insulin resistance in colon cancer patients.
Study design: A double-blinded, placebo controlled randomised, pilot study at the Surgery
Department of the Medical Center Alkmaar.
Study population: Thirty patients of male gender and any ethnicity, who will undergo
elective open abdominal colon surgery for colon cancer, aged 18-75 years.
Intervention: Patients will receive dipeptide alanyl-glutamine intravenously or enterally,
starting 24 hours prior to surgery, until 24 hours after surgery in the dosage of 0.5
g/kg/day, or saline (control group), for the same period of time.
Main study parameters/endpoints: The main study parameter is postoperative insulin
resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory
hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as
inflammatory pathways.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05280379 -
Trained Immunity in Thyroid Carcinoma and Colon Carcinoma
|
||
| Completed |
NCT01896778 -
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
|
N/A | |
| Terminated |
NCT01111292 -
Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT00996619 -
Measuring the Spectrum of Tissues During Endoscopy
|
N/A | |
| Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
| Recruiting |
NCT04147494 -
Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
|
Early Phase 1 | |
| Active, not recruiting |
NCT02991092 -
The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)
|
N/A | |
| Active, not recruiting |
NCT01696981 -
Screening for Colorectal Cancer in Older Patients (PLCO Screening Trial)
|
N/A | |
| Terminated |
NCT03137706 -
Characterization of Mechanical Tissue Properties in Patients With Pancreatic, Liver, or Colon Cancer
|
||
| Active, not recruiting |
NCT03151564 -
Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
|
N/A | |
| Recruiting |
NCT04959604 -
Lymph Node Mapping Via Flourescent Dye in Colon Cancer
|
N/A | |
| Completed |
NCT02890758 -
Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803
|
Phase 1 | |
| Recruiting |
NCT03026140 -
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer
|
Phase 2 | |
| Completed |
NCT03064308 -
The Assessment of the Feasibility of a Home Based Exercise Programme in the Older Patient Following Major Surgery
|
N/A | |
| Active, not recruiting |
NCT02432963 -
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT04505553 -
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05672342 -
Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors
|
Early Phase 1 | |
| Recruiting |
NCT03334383 -
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery
|
N/A | |
| Suspended |
NCT04955808 -
Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
|
||
| Completed |
NCT00122135 -
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
|
N/A |