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
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
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.
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