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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Standard treatment Plan 		This is the main arm of the study in which all 25 anticipated participants will be enrolled into.
  • Other: Exercise Training
    Virtually supervised exercise training for four weeks prior to cystectomy
  • Dietary Supplement: Nutritional Intervention
    Patients scheduled to undergo cystectomy will receive liquid Ensure supplemental shakes for 2 weeks prior to surgery and liquid Ensure supplemental shakes for 1 week postoperatively

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Matthew Mossanen, MD
617-732-6384
mmossanen@bwh.harvard.edu

Dana Farber Cancer Institute
Boston, Massachusetts 02115
Contact:
Matthew Mossanen, MD
617-732-6384
mmossanen@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Dana-Farber Cancer Institute

Study Contact

Matthew Mossanen, MD, MPH
617-732-6384
mmossanen@bwh.harvard.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.