NCT05715684Recruiting
Patient-Centered Surgical Prehabilitation
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- Mar 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT05715684
What you commit to
- Study type: Interventional
- Planned participants: 25
- From Mar 2023 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
- More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
- Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
- Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
- Using illicit drugs or abusing alcohol
- History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
Other illness
- The presence of metastatic cancer
- Be undergoing treatment for another type of cancer concurrently
- Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
- Patients with severe hepatic impairment as defined by Child-Pugh Class C. Patients with Child-Pugh Class A-B hepatic impairment are eligible for the study.
- A history of heart failure.
- Patients with heart failure.
Lab values
- Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
- Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
- Patients with end-stage renal disease as defined by GFR \<15.
Other
- Scheduled for a partial cystectomy
- Patients with complete gastrointestinal obstruction.
- Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds.
- Non-English-speaking patients
Who the study is looking for
- Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach.
- Patients between the ages 18 and 85 years
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
- Ileal conduit or ileal neobladder urinary diversion
- Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.