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Trial Title:
Patient-Centered Surgical Prehabilitation
NCT ID:
NCT05715684
Condition:
Bladder Cancer
Cystectomy
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Exercise Training
Description:
Virtually supervised exercise training for four weeks prior to cystectomy
Arm group label:
Standard treatment Plan
Intervention type:
Dietary Supplement
Intervention name:
Nutritional Intervention
Description:
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
Arm group label:
Standard treatment Plan
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Mossanen, MD
Phone:
617-732-6384
Email:
mmossanen@bwh.harvard.edu
Investigator:
Last name:
Matthew Mossanen, MD
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Mossanen, MD
Phone:
617-732-6384
Email:
mmossanen@bwh.harvard.edu
Investigator:
Last name:
Matthew Mossanen, MD
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
December 25, 2027
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Abbott Nutrition
Agency class:
Industry
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05715684
