Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery - Full Text View

Sponsored by:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00730808

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)

MedlinePlus related topics: Cancer Dietary Supplements

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	20
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test: Experimental 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;
Control: Placebo Comparator 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 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

rectal tumour with indication for elective low anterior resection
preoperative radiotherapy (5x5 Gy)
loop ileostoma or colostoma;

Exclusion Criteria:

preoperative chemotherapy
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

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

Contacts

Contact: Steffen Benzing, Dr.

+49 (0) 6172 686 7709

steffen.benzing@fresenius-kabi.com

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

Responsible Party:	Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH ( Dr. Steffen Benzing )
Study ID Numbers:	N-POB-04-NL
Study First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730808
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Fresenius Kabi:

Enteral nutritional regimen prior to surgery

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases

Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009