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Prehabilitation for Bladder Cancer Surgery (Prehab Trial)

N/A
Recruiting
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged between 18 and 85 years
American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
Must not have
Non-English-speaking patients
Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a prehab program can help people better prepare for a cystectomy surgery.

Who is the study for?
This trial is for adults aged 18-85 with bladder cancer who are fit enough for surgery (ASA class 1-4) and planning to undergo cystectomy. Participants must understand and consent to the study, not have metastatic cancer, severe organ impairment, or be on certain medications. Pregnant women and those not using birth control are excluded.
What is being tested?
The trial tests a prehabilitation program combining exercise training and nutritional intervention designed to prepare patients physically and nutritionally for bladder removal surgery (cystectomy).
What are the potential side effects?
While specific side effects aren't listed for this type of non-drug intervention, potential risks may include typical exercise-related injuries or issues related to dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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My health is rated between 1 to 4 on the ASA scale.
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I am a candidate for bladder removal surgery, including creating a new way for urine to leave my body.
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I have had surgery to redirect urine flow using part of my intestine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I haven't had chemotherapy for bladder cancer in the last month, but previous treatments are okay.
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I am pregnant, breastfeeding, or able to have children and not using birth control.
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I have a history of heart failure.
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I have a complete blockage in my digestive tract.
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My kidney function is very low (GFR <15).
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I have a feeding tube.
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I have severe liver problems.
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I have taken more than three doses of pain medication in the week before my surgery.
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I am scheduled for surgery to remove part of my bladder.
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I have had surgery to remove my colon, stomach, or have had a gastric bypass, colostomy, or ileostomy.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Discharge disposition
Length of stay
Number and type of minor and major complications
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard treatment PlanExperimental Treatment2 Interventions
This is the main arm of the study in which all 25 anticipated participants will be enrolled into.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Intervention
2011
Completed Phase 3
~690

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,109 Previous Clinical Trials
357,273 Total Patients Enrolled
Abbott NutritionIndustry Sponsor
172 Previous Clinical Trials
33,873 Total Patients Enrolled

Media Library

Patient-Centered Surgical Prehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05715684 — N/A
Bladder Cancer Research Study Groups: Standard treatment Plan
Bladder Cancer Clinical Trial 2023: Patient-Centered Surgical Prehabilitation Highlights & Side Effects. Trial Name: NCT05715684 — N/A
Patient-Centered Surgical Prehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715684 — N/A
~13 spots leftby Dec 2026
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