Back to resultsEffectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Primary Purpose
Rectal Tumors
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
PreOP Booster (food for special medical purposes)
Sponsored by
About this trial
This is an interventional supportive care trial for Rectal Tumors focused on measuring Enteral nutritional regimen prior to surgery
Eligibility 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)
Sites / Locations
- Medical Center Alkmaar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test
Control
Arm Description
Oral nutritional supplement: assignment according to consecutive random numbers.
Assignment according to consecutive random numbers.
Outcomes
Primary Outcome Measures
Immunoinflammatory parameters
Antioxidant / oxidant parameters
Ischemia / reperfusion injury parameters
Secondary Outcome Measures
pre-and postoperative discomfort (well-being)
hand grip strength
GI tolerance
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00730808
Brief Title
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
Official Title
Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fresenius Kabi
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Tumors
Keywords
Enteral nutritional regimen prior to surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Oral nutritional supplement: assignment according to consecutive random numbers.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Assignment according to consecutive random numbers.
Intervention Type
Dietary Supplement
Intervention Name(s)
PreOP Booster (food for special medical purposes)
Intervention Description
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
Primary Outcome Measure Information:
Title
Immunoinflammatory parameters
Time Frame
on day -2, -1, 1, 2, 3, 5, and 7
Title
Antioxidant / oxidant parameters
Time Frame
on day -2, 1, 3, 5, and 7
Title
Ischemia / reperfusion injury parameters
Time Frame
on day -2, 1, 3, 5, and 7
Secondary Outcome Measure Information:
Title
pre-and postoperative discomfort (well-being)
Time Frame
on day -1, and 0
Title
hand grip strength
Time Frame
on day -2, 1, 2, 3, 5, and 7
Title
GI tolerance
Time Frame
on day -1, 0, 1, 2, and 7
Title
Safety
Time Frame
on day -1, 0, 1, 2, 3, 5, and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A.M. van Leeuwen, Prof.
Organizational Affiliation
University Hospital Amsterdam; The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Center Alkmaar
City
Alkmaar
Country
Netherlands
12. IPD Sharing Statement
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Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
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