Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 15, 2026
October 1, 2024
2.7 years
May 29, 2013
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune and Inflammation Response
Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.
Change from Baseline to Day 30
Secondary Outcomes (3)
preservation of body weight and fat free mass (FFM)
Change from Baseline to 30 Days
count of infections after surgery
Change from Baseline to 30 Days
hospital readmission rate
Change from Baseline to 30 Days
Study Arms (2)
Impact Advanced Recovery®
EXPERIMENTAL3 briks daily (240 mL per brik) of Impact Advanced Recovery® to be take for 5 days before and after RC surgery
Boost Plus®
PLACEBO COMPARATOR3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery
Interventions
Eligibility Criteria
You may qualify if:
- Men undergoing RC surgery for primary bladder cancer
You may not qualify if:
- Patients with swallowing difficulties or unable to tolerate oral intake
- Evidence of metastatic disease
- Weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or BMI ≤ 18.5
- Patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial
- Active viral infections such as Human immunodeficiency virus (HIV) positive, hepatitis, or who have a known immunodeficient state
- Prior history of gouty arthritis or uric acid stones
- Patients with milk, soy, or fish allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jill Hamilton-Reeves, PhD RD LDlead
- American Cancer Society, Inc.collaborator
- Société des Produits Nestlé (SPN)collaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J, Holzbeierlein JM. Effects of Immunonutrition for Cystectomy on Immune Response and Infection Rates: A Pilot Randomized Controlled Clinical Trial. Eur Urol. 2016 Mar;69(3):389-92. doi: 10.1016/j.eururo.2015.11.019. Epub 2015 Nov 30.
PMID: 26654125RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jill Hamilton-Reeves, PhD, RD, LD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 29, 2013
First Posted
June 4, 2013
Study Start
July 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
April 15, 2026
Record last verified: 2024-10