Preparing patients for bladder cancer surgery
Patient-Centered Surgical Prehabilitation
This study tests a program that helps bladder cancer patients get stronger and healthier before their surgery to see if it improves their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05715684 on ClinicalTrials.gov |
What this trial studies
This research focuses on validating a prehabilitation program designed to prepare patients physically and nutritionally for cystectomy, a surgery for bladder cancer. The study tests a combination of interventions, including exercise training, nutritional support, and clinical assessments, to determine their effectiveness in improving recovery outcomes. Participants will undergo various assessments and training to enhance their physical condition before surgery. The goal is to identify the most effective interventions for future studies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who are scheduled for cystectomy and meet specific health criteria.
Not a fit: Patients scheduled for partial cystectomy or those with metastatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve recovery times and outcomes for patients undergoing cystectomy.
How similar studies have performed: Other studies have shown promise in using prehabilitation programs to enhance surgical recovery, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Matthew Mossanen, MD, MPH
- Email: mmossanen@bwh.harvard.edu
- Phone: 617-732-6384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.