NCT05715684 Patient-Centered Surgical Prehabilitation
| NCT ID | NCT05715684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-12-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-03-01 with a primary completion date of 2026-12-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach. 2. Patients between the ages 18 and 85 years 3. American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4 4. Ileal conduit or ileal neobladder urinary diversion 5. Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent Exclusion Criteria: 1. Scheduled for a partial cystectomy 2. Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy 3. More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery 4. The presence of metastatic cancer 5. Be undergoing treatment for another type of cancer concurrently 6. Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed. 7. 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.) 8. 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 9. Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery 10. Using illicit drugs or abusing alcohol 11. 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 12. Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.) 13. 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. 14. A history of heart failure. 15. Patients with end-stage renal disease as defined by GFR \<15. 16. Patients with heart failure. 17. Patients with complete gastrointestinal obstruction. 18. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds. 19. Non-English-speaking patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05715684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05715684 currently recruiting?
Yes, NCT05715684 is actively recruiting participants. Contact the research team at mmossanen@bwh.harvard.edu for enrollment information.
Where is the NCT05715684 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05715684 clinical trial?
NCT05715684 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 25 participants.
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