Bladder CancerPhase 4NCT03147586
Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy
A Phase 4 study testing Bio-tech and omega-3 plus in people with Bladder Cancer and Oncology, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Oncology, Infection
- What is being tested?
- Bio-tech and omega-3 plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 30 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions
- Willing to be randomized
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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.
- Conditions
- Bladder Cancer, Oncology, Infection, Complication, Muscle Invasive, Radical Cystectomy
- Being tested
- Bio-tech and omega-3 plus, placebo
- Keywords
- Immune Nutrition, Morbidity
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-tech and omega-3 plusDrug
immune nutrition : Bio-tech ( multivitamins and essential amino acids), and omega-3 plus (omega-3 fatty acids)
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system
measured by modified Dindo-Clavien system
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Mar 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion30 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Nabeeh, Mansoura University
- Investigators
- Atallah A. Shaaban, MD, Study chair, Urology and nephrology centerHassan Abo-Elenin, MD, Study director, Urology and nephrology centerAhmed Mosbah, MD, Study director, Urology and nephrology centerAhmed Harraz, MD, Principal investigator, Urology and nephrology centerAbdelwahab R. Hashem, Msc, Principal investigator, Urology and nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147586
- Sponsor's protocol ID
- MD/16.10.55
- Status last verified
- May 2017
- First submitted
- 12 Mar 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: meta-analyses by contact the Prof. Atallah Ahmed Shaaban MD (Study Chair)
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy and Bladder Substitutions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03147586
- Acronym / sponsor ID
- MD/16.10.55
- Conditions
- Bladder Cancer, Oncology, Infection, Complication, Muscle Invasive, Radical Cystectomy
- Keywords
- Immune Nutrition, Morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 30 Oct 2017 (estimated)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-tech and omega-3 plus | Active comparator | Drug: Bio-tech and omega-3 plusBio-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 |
| placebo | Placebo comparator | Drug: placeboplacebo powder 30 mg t.d.s plus placebo capsules t.d.s for 1 week before and 2 week after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions
- Willing to be randomized
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-tech and omega-3 plusimmune nutrition : Bio-tech ( multivitamins and essential amino acids), and omega-3 plus (omega-3 fatty acids) | Drug | Bio-tech and omega-3 plus |
| placeboplacebo | Drug | placebo |
Primary outcome
The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system
Time frame: 3 months
measured by modified Dindo-Clavien system
2 secondary outcomes
The effect of immune nutrition diet on nutritional status of radical cystectomy patients measured by validated nutritional assessment scores
Time frame: 3 months
The effect of immune nutrition diet on anthropometric measures of radical cystectomy patients measured by skinfold thickness in centimetres
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Yes. meta-analyses by contact the Prof. Atallah Ahmed Shaaban MD (Study Chair)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atallah A. Shaaban, MD study chair
Urology and nephrology center
Hassan Abo-Elenin, MD study director
Urology and nephrology center
Ahmed Mosbah, MD study director
Urology and nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bio-tech and omega-3 plus in people with Bladder Cancer and Oncology, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.