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Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy

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ClinicalTrials.gov Identifier: NCT03147586
Recruitment Status : Unknown
Verified May 2017 by Hossam Nabeeh, Mansoura University.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hossam Nabeeh, Mansoura University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Bladder Cancer Oncology Infection Complication Muscle Invasive Radical Cystectomy Drug: Bio-tech and omega-3 plus Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy and Bladder Substitutions: A Randomized Controlled Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bio-tech and omega-3 plus
Bio-tech (Biopharm pharmaceutical) powder 30 mg t.d.s. (contains multivitamins and essential amino acids) plus omega-3 plus (SEDICO pharmaceutical) capsules t.d.s (source for omega-3 fatty acids) 1 week before and 2 week after surgery
Drug: Bio-tech and omega-3 plus
immune nutrition : Bio-tech ( multivitamins and essential amino acids), and omega-3 plus (omega-3 fatty acids)

Placebo Comparator: placebo
placebo powder 30 mg t.d.s plus placebo capsules t.d.s for 1 week before and 2 week after surgery
Drug: placebo
placebo




Primary Outcome Measures :
  1. The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system [ Time Frame: 3 months ]
    measured by modified Dindo-Clavien system


Secondary Outcome Measures :
  1. The effect of immune nutrition diet on nutritional status of radical cystectomy patients measured by validated nutritional assessment scores [ Time Frame: 3 months ]
    measured by validated nutritional assessment scores

  2. The effect of immune nutrition diet on anthropometric measures of radical cystectomy patients measured by skinfold thickness in centimetres [ Time Frame: 3 months ]
    measured by skinfold thickness in centimetres



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147586


Locations
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Egypt
Urology and Nephrology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Atallah A. Shaaban, MD Urology and nephrology center
Study Director: Hassan Abo-Elenin, MD Urology and nephrology center
Study Director: Ahmed Mosbah, MD Urology and nephrology center
Principal Investigator: Ahmed Harraz, MD Urology and nephrology center
Principal Investigator: Abdelwahab R. Hashem, Msc Urology and nephrology center

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Responsible Party: Hossam Nabeeh, Msc, Mansoura University
ClinicalTrials.gov Identifier: NCT03147586    
Other Study ID Numbers: MD/16.10.55
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Atallah Ahmed Shaaban MD (Study Chair)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hossam Nabeeh, Mansoura University:
Immune Nutrition
Morbidity
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases