Cancer, BladderNCT05822518
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
A study testing Neo-mune powder (otsuka pharmaceutical) and Dipeptiven solution (Fresenius Kabi pharmaceutical) in people with Cancer, Bladder and Cystostomy; Complications, run by Menoufia University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Bladder, Cystostomy; Complications
- What is being tested?
- Neo-mune powder (otsuka pharmaceutical) and Dipeptiven solution (Fresenius Kabi pharmaceutical)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Feb 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with CT showing bladder mass with radiological staging of T2 or T3.
- Patients pathologically proven to have cancer bladder.
- Patients undergoing radical cystectomy with ileal conduit.
- The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.
Who cannot join
- Coagulopathy.
- Distant metastasis.
- Body mass index less than 18.5.
- Relevant food allergies.
- Severe renal and hepatic insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.
- Conditions
- Cancer, Bladder, Cystostomy; Complications
- Being tested
- Neo-mune powder (otsuka pharmaceutical), Dipeptiven solution (Fresenius Kabi pharmaceutical)
- Keywords
- radical cystectomy, complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-mune powder (otsuka pharmaceutical)Dietary supplement
- Preoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 3 days.
- Postoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 2 weeks starting when the intestinal sounds are audible.
Dipeptiven solution (Fresenius Kabi pharmaceutical)Drug
Dipeptiven (Fresenius Kabi pharmaceutical) solution 50 mg o.d IV ( contains L-ananyl-L-glutamine dipeptide) post operatively for 5 days starting from the operation day.
| Study group | Role | What they receive |
|---|---|---|
| conventional protocol group | No intervention | patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol. |
| immune enhancing nutrition protocol group | Active comparator | patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively. Receives: Dietary Supplement: Neo-mune powder (otsuka pharmaceutical); Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
The number of postoperative complications, either infectious or non-infectious. Postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.
Measured: 30 days
Wound healing
The number of properly healed wounds. wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
Measured: 30 days
infectious complications
infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
Measured: 30 days
Secondary outcomes (2)
Length of hospital stay
will be measured by number of days of hospital stay.
Measured: 30 days
Length of ICU stay
will be measured by number of days of ICU stay.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Jun 2022
- Primary completion30 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BladderStudies of the same condition, open and under way.
- More trials run by Menoufia 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822518
- Sponsor's protocol ID
- Nutrition in R.cystectomy
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT05822518
- Acronym / sponsor ID
- Nutrition in R.cystectomy
- Conditions
- Cancer, Bladder, Cystostomy; Complications
- Keywords
- radical cystectomy, complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 20 Apr 2023 (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.
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional protocol group | No intervention | –patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol. |
| immune enhancing nutrition protocol group | Active comparator | Dietary Supplement: Neo-mune powder (otsuka pharmaceutical), Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CT showing bladder mass with radiological staging of T2 or T3.
- Patients pathologically proven to have cancer bladder.
- Patients undergoing radical cystectomy with ileal conduit.
- The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.
Key exclusion criteria (5 listed)
- Coagulopathy.
- Distant metastasis.
- Body mass index less than 18.5.
- Relevant food allergies.
- Severe renal and hepatic insufficiency.
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 |
|---|---|---|
| Neo-mune powder (otsuka pharmaceutical)* Preoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 3 days. * Postoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 2 weeks starting when the intestinal sounds are audible. | Dietary supplement | immune enhancing nutrition protocol group |
| Dipeptiven solution (Fresenius Kabi pharmaceutical)Dipeptiven (Fresenius Kabi pharmaceutical) solution 50 mg o.d IV ( contains L-ananyl-L-glutamine dipeptide) post operatively for 5 days starting from the operation day. | Drug | immune enhancing nutrition protocol group |
Primary outcome
Postoperative complications
Time frame: 30 days
The number of postoperative complications, either infectious or non-infectious. Postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.
Wound healing
Time frame: 30 days
The number of properly healed wounds. wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
infectious complications
Time frame: 30 days
infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
2 secondary outcomes
Length of hospital stay
Time frame: 30 days
Length of ICU stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo-mune powder (otsuka pharmaceutical) and Dipeptiven solution (Fresenius Kabi pharmaceutical) in people with Cancer, Bladder and Cystostomy; Complications, run by Menoufia 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative complications (time frame: 30 days). The study lists 3 primary outcomes in all. 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 26 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.