Bladder Cancer study: Exercise Training vs Nutritional Intervention
Official title Patient-Centered Surgical Prehabilitation
ClinicalTrials.gov ID: NCT05715684
What this study is testing
- What it's testing
- The study aims to see if a physical and nutrition program can safely prepare patients for bladder removal surgery.
- Who it's for
- Adults diagnosed with bladder cancer who are planning to have a cystectomy.
- What's involved
- Participants will follow a set of exercise and nutrition activities before their surgery, with regular check‑ins by the study team.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.