Bladder Cancer Clinical Trial
Official title:
Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy and Bladder Substitutions: A Randomized Controlled Trial
Verified date | May 2017 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomised double-blinded placebo-controlled phase IV trial with two parallel treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks peri-radical cystectomy. Patients will be stratified according to the gender, body mass index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The primary end-point is to determine, in intention to treat analysis, the influence of IND on 90-day postoperative morbidity. Secondary study end-points will be the effect of IND on infectious as well as non-infectious complications over 90 days, compliance and adverse effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish patients' recruitment within 24 months
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | October 30, 2017 |
Est. primary completion date | October 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions - Willing to be randomized Exclusion Criteria: - Non-compliance and /or allergy with oral nutrition diet. - Non-organ confined disease - Associated comorbidities e.g. Gout and Rheumatoid arthritis - Weight loss more than10% (with respect to usual body weight) in the past 6 months - Hepatic dysfunction (Child-Pugh class more than B), and renal dysfunction (serum creatinine level more than3 mg/dL, hemodialysis), - Untreated infections - Immune disorders. - Chronic gastrointestinal tract disease eg.crohn's disease or previous surgery. |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system | measured by modified Dindo-Clavien system | 3 months | |
Secondary | The effect of immune nutrition diet on nutritional status of radical cystectomy patients measured by validated nutritional assessment scores | measured by validated nutritional assessment scores | 3 months | |
Secondary | The effect of immune nutrition diet on anthropometric measures of radical cystectomy patients measured by skinfold thickness in centimetres | measured by skinfold thickness in centimetres | 3 months |
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