Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00730808
First received: August 5, 2008
Last updated: May 18, 2010
Last verified: May 2010
  Purpose

The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.


Condition Intervention
Rectal Tumors
Dietary Supplement: PreOP Booster (food for special medical purposes)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Immunoinflammatory parameters [ Time Frame: on day -2, -1, 1, 2, 3, 5, and 7 ] [ Designated as safety issue: No ]
  • Antioxidant / oxidant parameters [ Time Frame: on day -2, 1, 3, 5, and 7 ] [ Designated as safety issue: No ]
  • Ischemia / reperfusion injury parameters [ Time Frame: on day -2, 1, 3, 5, and 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pre-and postoperative discomfort (well-being) [ Time Frame: on day -1, and 0 ] [ Designated as safety issue: No ]
  • hand grip strength [ Time Frame: on day -2, 1, 2, 3, 5, and 7 ] [ Designated as safety issue: No ]
  • GI tolerance [ Time Frame: on day -1, 0, 1, 2, and 7 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: on day -1, 0, 1, 2, 3, 5, and 7 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Oral nutritional supplement: assignment according to consecutive random numbers.
Dietary Supplement: PreOP Booster (food for special medical purposes)
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
Placebo Comparator: Control
Assignment according to consecutive random numbers.
Dietary Supplement: PreOP Booster (food for special medical purposes)
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
  • preoperative radiotherapy (5x5 Gy) or chemoradiation
  • loop ileostoma or colostoma;

Exclusion Criteria:

  • severe malnutrition
  • severe renal insufficiency
  • diabetes mellitus I or II
  • concomitant thyroid medication
  • corticosteroids
  • diuretic medication and antihypertensive medication
  • known or suspected allergy to any component of the investigational product(s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730808

Locations
Netherlands
Medical Center Alkmaar
Alkmaar, Netherlands
Sponsors and Collaborators
Fresenius Kabi
Investigators
Study Chair: Paul A.M. van Leeuwen, Prof. University Hospital Amsterdam; The Netherlands
  More Information

No publications provided

Responsible Party: Dr. Steffen Benzing, Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00730808     History of Changes
Other Study ID Numbers: N-POB-04-NL
Study First Received: August 5, 2008
Last Updated: May 18, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Fresenius Kabi:
Enteral nutritional regimen prior to surgery

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014