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

NCT03147586 | Unknown Phase 4

• 1 other identifier: MD/16.10.55
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Bladder Cancer; Oncology; Infection; Complication; Muscle Invasive; Radical Cystectomy

Keywords

Immune Nutrition; Morbidity

Outcome Measures

Primary Outcomes (1)

• The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system

  measured by modified Dindo-Clavien system

  3 months

Secondary Outcomes (2)

• The effect of immune nutrition diet on nutritional status of radical cystectomy patients measured by validated nutritional assessment scores

  3 months

• The effect of immune nutrition diet on anthropometric measures of radical cystectomy patients measured by skinfold thickness in centimetres

  3 months

Study Arms (2)

Bio-tech and omega-3 plus

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Bio-tech and omega-3 plus DRUG

immune nutrition : Bio-tech ( multivitamins and essential amino acids), and omega-3 plus (omega-3 fatty acids)

Bio-tech and omega-3 plus

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions
• Willing to be randomized

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms; Infections

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Atallah A. Shaaban, MD

  Urology and nephrology center

  STUDY CHAIR

• Hassan Abo-Elenin, MD

  Urology and nephrology center

  STUDY DIRECTOR

• Ahmed Mosbah, MD

  Urology and nephrology center

  STUDY DIRECTOR

• Ahmed Harraz, MD

  Urology and nephrology center

  PRINCIPAL INVESTIGATOR

• Abdelwahab R. Hashem, Msc

  Urology and nephrology center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: May 10, 2017
• Study Start: March 1, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)