Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03147586
Other study ID # MD/16.10.55
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received March 12, 2017
Last updated May 9, 2017
Start date March 1, 2017
Est. completion date October 30, 2017

Study information

Verified date May 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Radical cystectomy (RC) with pelvic lymphadenectomy is established as the gold standard surgical treatment of muscle invasive bladder cancer. Major complication rates at 90 days as high as 25% have been reported using a standardized reporting methodology even with the use of enhanced recovery protocol after surgery (ERAS), high lighting the significance of identification of the potential predictors to alleviate patients suffering after this complex procedure.

A major preoperative potentially reversible risk factor for severe postoperative morbidity is nutritional status, even; it is considered recently the missed ring in the all available morbidity prognostic indices. This was typically proving in other kinds of cancer. For instance, it has been shown that patients at nutritional risk have had significantly postoperative complications 10% as high as compared to those not at nutritional risk as well as elevated rates of anastomotic leak and infections after colorectal surgery. Likewise, in an observational trial, there was an increased risk of postoperative complications in malnourished patients undergoing pneumonectomy for lung cancer.Furthermore, the hazardous impact of malnutrition does extend beyond the potential morbidity to increased cost, hospital stay, and readmission rates. Not surprisingly, the prognostic nutritional index was shown, additionally, to influence the survival after total gastrectomy for patients with gastric cancer.

With respect to urological literature, the incidence of malnutrition amany surgical candidates largely differs according to the methodology implicated, ranging from 26-43% according to the nutritional index scoring system and 19% using serum albumin level and weight loss and body mass index. Moreover, the influence of poor nutritional status on postoperative morbidity has been clearly identified.

Johnson et al have demonstrated an increased incidence of postoperative complications from 55% to 67% for patients with nutritional deficiency portrayed by low serum albumin level. Similarly yet in gynecological cancers, hypoalbuminemia was an independent surrogate for adverse postoperative events. Therefore, it has been highly recommended to implicate innovative nutritional interventions for optimizing the outcome after radical cystectomy.What is worth mention is that the active ingredients of immune diet were considerably the same across studies on different cancers, and principally including arginine, omega-3 fatty acids, and glutamine which have been proved to ameliorate the inflammatory and stress response of the body to surgery, and consequently, minimizing the postoperative morbidity. It is also particularly important to note that oral diet had been valued over parenteral injections concerning efficacy and safety.

To date, only two pilot trials have been applied elucidating the beneficial effect of immune nutrition diet (IND) on postoperative morbidity and surgery-induced inflammations after radical cystectomy.Hamilton-Reeves and associates have represented a reduction of 33% and 39% in overall complications and infection rates, respectively. Then again, the authors have shown a potential effect of the IND on the laboratory markers of inflammation. Equally important, a decline by just below the half, falling from 77% to 40% complications rate, and by more than half, from 66% to 20% infection rate, were noted in a prospective cohort compared with historical control.

Yet, these studies were limited by the relative-low number of patients as both were considered "pilot". In addition, neither of both studies had determined the nutritional status of the candidates prior to enrolment in the study protocol. Furthermore, there was no control for some confounding variables like gender, body mass index and type of diversion, which definitely would affect the primary outcome of these studies.

In this context, this protocol was designed to assess the impact of IND on patients undergoing radical cystectomy controlling for every single potential confounding variable.


Recruitment information / eligibility

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.

Study Design


Intervention

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
placebo

Locations

Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06034015 - A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers Phase 1
Recruiting NCT04235764 - En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Completed NCT02371447 - VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer Phase 1/Phase 2
Recruiting NCT04081246 - Transurethral Modified En Bloc Resection For Large Bladder Tumours. N/A
Recruiting NCT06059547 - Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer Phase 2
Terminated NCT04779489 - Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer N/A
Not yet recruiting NCT04493489 - Propranolol Adjuvant Treatment of Bladder Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04537221 - Nordic Cystectomy Study III - Transfusion
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05562791 - A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer Phase 1
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Completed NCT02781428 - To Detect the Sensitivity of the UroMark Assay
Recruiting NCT04738630 - Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer Phase 2
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03978624 - Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A