Radical Cystectomy, Nutrition and Convalescence

RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Neoplasms; Bladder Cancer; Cystectomy
• Intervention / Treatment: Dietary supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bladder cancer
• Ability to give an informed consent

Exclusion Criteria:

• Previous radiation therapy at the pelvic area
• Ureterocutaneostomy
• Robot-assisted surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parenteral nutrition; Patients receives a goal-directed nutritional intervention combining oral intake and parenteral nutrition	Dietary supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi
No Intervention: Standard treatment; patients receives a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	meassured pre-operatively + 6 and 12 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Change from baseline weight at 6 and 12 weeks following the date of surgery	preoperatively, 6 and 12 weeks postop
hand grip strength	Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery	pre-operatively, 6 days and 6 weeks postop
length of hospital stay		12 week follow-up
Time to bowel recovery		12 week follow-up

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): September 12, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Quality of Life; Enteral nutrition; Nutrition Therapy; Parenteral nutrition, total
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Urinary Bladder Neoplasms; Convalescence
• Other Study ID Numbers: H-2-2011-114