Bladder Cancer Clinical Trial

Patient-Centered Surgical Prehabilitation

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.

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Full 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

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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 years
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:

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
The presence of metastatic cancer
Be undergoing treatment for another type of cancer concurrently
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 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

Study is for people with:

Bladder Cancer

Estimated Enrollment:

25

Study ID:

NCT05715684

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Matthew Mossanen, MD
Contact
617-732-6384
[email protected]
Matthew Mossanen, MD
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Matthew Mossanen, MD
Contact
617-732-6384
[email protected]
Matthew Mossanen, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

25

Study ID:

NCT05715684

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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