Clinical trial NCT05715684: Patient-Centered Surgical Prehabilitation
Official title: Patient-Centered Surgical Prehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Cystectomy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2023-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This research study is testing the efficacy of the prehabilitation study which is a set of investigational interventions and also tries to define the most appropriate and effective set type of interventions to use for further studies. "Investigational" means that the intervention is being studied. In this research study, the investigators hope to learn whether or not this combination of prehabilitation interventions has an impact on the recoverability of participants who will undergo cystectomy or bladder removal surgery. The 5 interventions that make up the prehabilitation study are:

* Participant Interview (If one of the first ten participants)
* Exercise Testing
* Exercise Training
* Nutritional Support
* Clinical Assessment of Nutritional Status

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

Primary outcomes:
measure: Total days hospitalized within 30-days of surgery
timeFrame: 60 months
measure: Length of stay
timeFrame: 60 months
measure: Number and type of minor and major complications
timeFrame: 60 months
measure: Discharge disposition
timeFrame: 60 months
measure: Readmissions
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
References: