Actively Recruiting
Patient-Centered Surgical Prehabilitation
Led by Dana-Farber Cancer Institute · Updated on 2023-03-22
25
Participants Needed
2
Research Sites
251 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
A
Abbott Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Patient-Centered Surgical Prehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach
- Aged between 18 and 85 years
- American Society of Anesthesiologists (ASA) Physical Status Score of class 1 to 4
- Planned ileal conduit or ileal neobladder urinary diversion
- Able to understand study procedures, agree to participate, and provide informed consent
You will not qualify if you...
- Scheduled for a partial cystectomy
- Previous total colectomy, gastrectomy, gastric bypass, or functional colostomy or ileostomy
- More than three doses of opioids within 7 days before surgery
- Presence of metastatic cancer
- Undergoing treatment for another type of cancer concurrently
- Chemotherapy for bladder cancer within 1 month before surgery (prior neoadjuvant chemotherapy allowed)
- Pregnant, lactating, or not postmenopausal and of childbearing potential without accepted birth control
- Participated in another investigational study within 30 days before surgery or planning to enroll during this study
- Clinically significant laboratory abnormalities at screening that would cancel surgery
- Using illicit drugs or abusing alcohol
- History of surgeries, illnesses, or behaviors that may affect study results or pose risk
- Severe dementia impacting daily functioning
- Severe hepatic impairment (Child-Pugh Class C)
- History of heart failure
- End-stage renal disease with GFR <15
- Complete gastrointestinal obstruction
- Presence of gastrostomy, jejunostomy, or need for enteral tube feeds
- Non-English-speaking patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Matthew Mossanen, MD, MPH
CONTACT
N
Nnamdi Onochie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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