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Official title The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
ClinicalTrials.gov ID: NCT05726786
What this study is testing
What is Immunonutrition?
Immunonutrition is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient undergoing open cystectomy (for all reasons)
- Age ≥18 years
- Ability and willingness to provide informed consent documented by signature
You likely can't join if
- Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin
- Severe diarrhoea requiring medical attention
- Current treatment with any immunosuppressive drug
- In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the...
- Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)
- Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.
See the full eligibility criteria
- Patient undergoing open cystectomy (for all reasons)
- Age ≥18 years
- Ability and willingness to provide informed consent documented by signature
- Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin
- Severe diarrhoea requiring medical attention
- Current treatment with any immunosuppressive drug
- In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient...
- Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)
- Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Use of IN independently of the study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Emergency procedure (less than 7 days between screening and surgery)
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
- Bern, Switzerland
- Geneva, Switzerland
- Rennaz, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland; Bern, Switzerland; Geneva, Switzerland; Rennaz, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.