Radical Cystectomy, Nutrition and Convalescence

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238886
• Other study ID #: H-2-2011-114
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: September 10, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Bladder cancer

• Ability to give an informed consent

Exclusion Criteria:

• Previous radiation therapy at the pelvic area

• Ureterocutaneostomy

• Robot-assisted surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bladder Cancer
• Convalescence
• Cystectomy
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi

Locations

Country	Name	City	State
Denmark	Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Body weight	Change from baseline weight at 6 and 12 weeks following the date of surgery	preoperatively, 6 and 12 weeks postop	No
Secondary	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	No
Secondary	length of hospital stay		12 week follow-up	No
Secondary	Time to bowel recovery		12 week follow-up	No