Gastrointestinal Tumors Clinical Trial
— GlutaminprojecOfficial title:
The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies - A Randomized, Placebo-controlled Pilot Study
Verified date | February 2018 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Malnutrition occurs in up to 50% of patients requiring elective surgery for neoplastic
diseases. It exerts a detrimental influence on outcome of surgery, because it can suppress
immune function, exaggerate stress response and cause organ system dysfunction. Increased
susceptibility to infection, protracted wound healing, impaired blood clotting and vessel
wall fragility have been shown to be the leading causes of postoperative morbidity and
mortality in malnourished patients undergoing major surgical resections.
This trial is designed as a prospective randomized, double-blinded, placebo-controlled pilot
study in a academic single center in Switzerland. A total of 50 malnourished patients with
gastro-intestinal tumors will receive orally glutamine or placebo-treatment during a period
of 5 days prior to surgery. The investigators hypothesize that oral Glutamine administration
is feasible, well tolerated, will decrease postoperative morbidity, will suppress
postoperative cell damage and inflammatory response, and will improve the perioperative
immunocompetence of the patients.
Status | Completed |
Enrollment | 42 |
Est. completion date | February 12, 2018 |
Est. primary completion date | February 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed and surgically resectable carcinomas - Candidates for elective surgery with an estimated surgical stress score - A Nutritional Risk Screening 2002 (NRS-200232) score =3 - Age = 18 years - Completed primary immunization with tetanus toxoid - Last tetanus booster =10 years back - Informed consent Exclusion Criteria - Refusal to participate - Clinically relevant alterations of the pulmonary renal of hepatic function - Insulin-dependent diabetes mellitus - Pre-existing autoimmune diseases and immune-deficiencies - Neutropenia - Pregnancy - Age <18 years - Last tetanus booster <10 years back - Ongoing infection - Intestinal obstruction at the time of entry into the study |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of visceral surgery and transplant surgery, Berne University Hospital | Berne |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Fresenius Kabi |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity | 6 weeks | ||
Secondary | Postoperative cell damage | Up to seven days after surgery | ||
Secondary | Inflammatory response | Up to seven days after surgery | ||
Secondary | Nutritional status | Up to seven days after surgery | ||
Secondary | Perioperative immunocompetence | Seven and one day(s) before surgery. Postoperative week 1 and 6. |
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