Preparing patients for bladder cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Home IV fluid infusions after radical cystectomy

  This trial will test whether giving home IV fluids after radical cystectomy for bladder cancer reduces 90-day hospital readmissions.

  Recruiting Johns Hopkins University · Baltimore, Maryland and 1 other locations · NCT07225205

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Urinary Cell-Free DNA Test for Urothelial Cancer Origin

  This study tests a urine-based cell-free DNA test to help diagnose urothelial cancer and identify whether it started in the bladder or upper urinary tract in adults.

  Recruiting Ruijin Hospital · Shanghai · NCT07888374

• BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy

  This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.

  Recruiting at 2 sites Phase 3 SystImmune Inc. · Macon, Georgia and 1 other locations · NCT07869836

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

  This trial tests whether adding Sac-TMT and pembrolizumab to chemoradiation helps people with muscle-invasive bladder cancer live longer without the cancer growing or returning.

  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Personalized 3D Tumoroids from Your Tumor to Test Treatments

  Researchers are using patient tumor tissue and blood to grow personalized 3D, vascularized tumoroids with autologous immune cells to help tailor treatments for kidney, bladder, and prostate cancers.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07820566

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.