NCT01552291

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

5.8 years

First QC Date

March 5, 2012

Last Update Submit

February 12, 2018

Conditions

MalnourishmentGastrointestinal Tumors

Keywords

MalnourishmentGastrointestinal tumorsImmunocompetence

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    6 weeks

Secondary Outcomes (4)

  • Postoperative cell damage

    Up to seven days after surgery

  • Inflammatory response

    Up to seven days after surgery

  • Nutritional status

    Up to seven days after surgery

  • Perioperative immunocompetence

    Seven and one day(s) before surgery. Postoperative week 1 and 6.

Study Arms (2)

Glutamin

ACTIVE COMPARATOR
Dietary Supplement: Glutamine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GlutamineDIETARY_SUPPLEMENT

30g oral glutamine / day for 5 days before surgery. Glutamine is an important nonessential amino acid and its intracellular concentration is much higher than that of other amino acids. Glutamine is released in large quantities from skeletal muscle and serves as an important carrier and donor of nitrogen

Glutamin
PlaceboDRUG

30g oral maltodextrin / day for 5 days before surgery

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of visceral surgery and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

MalnutritionDigestive System Neoplasms

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsDigestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Beat Schnüriger, PD Dr. med.

    Department of visceral surgery and transplant surgery, Berne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 13, 2012

Study Start

May 1, 2012

Primary Completion

February 10, 2018

Study Completion

February 12, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

CH(1)