Radical Cystectomy, Nutrition and Convalescence

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02238886
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasms; Cystectomy; Bladder Cancer	Dietary Supplement: Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire) [meassured pre-operatively + 6 and 12 weeks following surgery]

   Change from baseline HRQoL at 6 and 12 weeks following surgery

Secondary Outcome Measures

1. Body weight [preoperatively, 6 and 12 weeks postop]

   Change from baseline weight at 6 and 12 weeks following the date of surgery

2. hand grip strength [pre-operatively, 6 days and 6 weeks postop]

   Change from baseline hand grip strength at 6 days and 6 weeks following the date of surgery

3. length of hospital stay [12 week follow-up]

4. Time to bowel recovery [12 week follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Bladder cancer

• Ability to give an informed consent

Exclusion Criteria:

• Previous radiation therapy at the pelvic area

• Ureterocutaneostomy

• Robot-assisted surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Line Noes Lydom, Clinical nurse specialist, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02238886
• Other Study ID Numbers: H-2-2011-114
• First Posted: Sep 12, 2014
• Last Update Posted: Sep 12, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Line Noes Lydom, Clinical nurse specialist, Rigshospitalet, Denmark: Quality of Life; Enteral nutrition; Nutrition Therapy; Parenteral nutrition, total
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Convalescence

Study Results

No Results Posted as of Sep 12, 2014