Clinical trial · Interventional
Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
NCT02655081CI-TRIAL-00029751IMPACTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. The investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. Secondary outcome measures will include differences in length of stay and complication rate between groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high arginine nutritional supplement (Nestle's Impact AR) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary supplement
- description
- Subjects will receive high arginine nutritional supplement (Nestle's Impact AR), prior to cystectomy
- interventionNames
- Dietary Supplement: high arginine nutritional supplement (Nestle's Impact AR)
Primary outcomes (1)
- measure
- Safety, tolerability and adherence to supplementation regimen."
- timeFrame
- 4 months
- description
- Investigator will report on any adverse events from supplementation as well as patient adherence to regimen.
Secondary outcomes (2)
- measure
- Incidence of 90-day overall and infectious complication rates. I
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Any adult patient seen at one of the aforementioned UPMC facilities who carries a diagnosis of bladder cancer and is considered a candidate for radical cystectomy for treatment. Exclusion Criteria: * Minors \< 18 years of age, patients not considered surgical candidates, patients who do not go on to undergo radical cystectomy. Patients with Glomerular Filtration Rate (GFR) \< 30 will also be excluded in an attempt to limit protein intake of patients with Stage IV and V Chronic Kidney Disease. Diabetic patients will be allowed to participate.
References
Publications (11)
- BACKGROUNDBraga M, Gianotti L, Radaelli G, Vignali A, Mari G, Gentilini O, Di Carlo V. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999 Apr;134(4):428-33. doi: 10.1001/archsurg.134.4.428. PMID 10199318
- BACKGROUNDShabsigh A, Korets R, Vora KC, Brooks CM, Cronin AM, Savage C, Raj G, Bochner BH, Dalbagni G, Herr HW, Donat SM. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol. 2009 Jan;55(1):164-74. doi: 10.1016/j.eururo.2008.07.031. Epub 2008 Jul 18. PMID 18675501
- BACKGROUNDLee CT, Madii R, Daignault S, Dunn RL, Zhang Y, Montie JE, Wood DP Jr. Cystectomy delay more than 3 months from initial bladder cancer diagnosis results in decreased disease specific and overall survival. J Urol. 2006 Apr;175(4):1262-7; discussion 1267. doi: 10.1016/S0022-5347(05)00644-0. PMID 16515975
- BACKGROUNDGibbs J, Cull W, Henderson W, Daley J, Hur K, Khuri SF. Preoperative serum albumin level as a predictor of operative mortality and morbidity: results from the National VA Surgical Risk Study. Arch Surg. 1999 Jan;134(1):36-42. doi: 10.1001/archsurg.134.1.36. PMID 9927128
- BACKGROUNDGregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12. PMID 21074802
- BACKGROUNDHollenbeck BK, Miller DC, Taub DA, Dunn RL, Khuri SF, Henderson WG, Montie JE, Underwood W 3rd, Wei JT. The effects of adjusting for case mix on mortality and length of stay following radical cystectomy. J Urol. 2006 Oct;176(4 Pt 1):1363-8. doi: 10.1016/j.juro.2006.06.015. PMID 16952633