Back to resultsRadical Cystectomy, Nutrition and Convalescence
Primary Purpose
Urinary Bladder Neoplasms, Cystectomy, Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Bladder Neoplasms focused on measuring Quality of Life, Enteral nutrition, Nutrition Therapy, Parenteral nutrition, total
Eligibility Criteria
Inclusion Criteria:
- Bladder cancer
- Ability to give an informed consent
Exclusion Criteria:
- Previous radiation therapy at the pelvic area
- Ureterocutaneostomy
- Robot-assisted surgery
Sites / Locations
- Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parenteral nutrition
Standard treatment
Arm Description
Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition
patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery
Outcomes
Primary Outcome Measures
Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
Change from baseline HRQoL at 6 and 12 weeks following surgery
Secondary Outcome Measures
Body weight
Change from baseline weight at 6 and 12 weeks following the date of surgery
hand grip strength
Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery
length of hospital stay
Time to bowel recovery
Full Information
NCT ID
NCT02238886
First Posted
September 5, 2014
Last Updated
September 10, 2014
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02238886
Brief Title
Radical Cystectomy, Nutrition and Convalescence
Official Title
RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether a goal directed nutritional intervention can reduce the convalescence period for patients undergoing radical cystectomy (RC).
The aim is to examine the effect on quality of life of a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery versus a goal-directed nutritional intervention combining oral intake and parenteral nutrition, in patients undergoing RC.
Detailed Description
The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area, ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of the patient's total energy and protein needs are met during hospitalization.
Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay, time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed in collaboration with a statistician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Cystectomy, Bladder Cancer
Keywords
Quality of Life, Enteral nutrition, Nutrition Therapy, Parenteral nutrition, total
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parenteral nutrition
Arm Type
Experimental
Arm Description
Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
Primary Outcome Measure Information:
Title
Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
Description
Change from baseline HRQoL at 6 and 12 weeks following surgery
Time Frame
meassured pre-operatively + 6 and 12 weeks following surgery
Secondary Outcome Measure Information:
Title
Body weight
Description
Change from baseline weight at 6 and 12 weeks following the date of surgery
Time Frame
preoperatively, 6 and 12 weeks postop
Title
hand grip strength
Description
Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery
Time Frame
pre-operatively, 6 days and 6 weeks postop
Title
length of hospital stay
Time Frame
12 week follow-up
Title
Time to bowel recovery
Time Frame
12 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bladder cancer
Ability to give an informed consent
Exclusion Criteria:
Previous radiation therapy at the pelvic area
Ureterocutaneostomy
Robot-assisted surgery
Facility Information:
Facility Name
Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Radical Cystectomy, Nutrition and Convalescence
We'll reach out to this number within 24 hrs