Comparing Alvimopan to placebo for bowel recovery after bladder cancer surgery
A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
This study is testing if a medication called Alvimopan can help people recover their bowel function faster after bladder cancer surgery compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03216525 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Alvimopan in promoting faster gastrointestinal recovery in patients undergoing radical cystectomy with urinary diversion. It is a prospective, randomized, double-blind study involving 136 participants, who will be divided into two groups: one receiving Alvimopan and the other receiving a placebo. The primary outcome is the time taken for patients to tolerate solid food and have their first bowel movement post-surgery. This approach seeks to control for confounding factors and provide robust data on the intervention's efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 undergoing radical cystectomy and urinary diversion.
Not a fit: Patients scheduled for partial cystectomy or with significant prior gastrointestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and better overall outcomes for patients undergoing bladder cancer surgery.
How similar studies have performed: Previous studies have shown promise with Alvimopan in similar surgical contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing radical cystectomy and urinary diversion via open or robotic approach. * Man or woman between the ages of 18 and 85. * 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 Exclusion criteria: * Patients who met any of the following criteria were excluded from participating in the study: * Scheduled for a partial cystectomy * 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. * 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.) * 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 * Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery * 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 * 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. * Patients with end-stage renal disease. * Patients with heart failure. . * Patients with complete gastrointestinal obstruction.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mark A Preston, MD — Brigham and Women's Hospital
- Study coordinator: Martin Barylak
- Email: mbarylak@bwh.harvard.edu
- Phone: 6175258274
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.