← Back to all trials
Not Yet Recruiting
NCT05715684
Patient-Centered Surgical Prehabilitation
Conditions: Bladder Cancer, Cystectomy
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 25
Sponsor: Dana-Farber Cancer Institute
Location: United States
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: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 yearsAmerican Society of Anesthesiologists (ASA) Physical Status Score of class 1-4Ileal conduit or ileal neobladder urinary diversionAble to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consentExclusion Criteria:Scheduled for a partial cystectomyPrevious total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomyMore than three doses of opioids (oral or parenteral) within 7 days before the day of surgeryThe presence of metastatic cancerBe undergoing treatment for another type of cancer concurrentlyChemotherapy 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 studyClinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgeryUsing illicit drugs or abusing alcoholHistory 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 proceduresPatients 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 end-stage renal disease as defined by GFR <15.Patients with heart failure.Patients with complete gastrointestinal obstruction.Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds.Non-English-speaking patients
Source: ClinicalTrials.gov (NCT05715684). StuddyBuddy aggregates publicly available trial information.