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RecruitingNCT05715684PrehabUpdated Sep 30, 2026

Patient-Centered Surgical Prehabilitation

An interventional study of Exercise Training and Nutritional Intervention in Bladder Cancer and Cystectomy, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Bladder Cancer
  • Cystectomy
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • 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 · Dietary Supplement: Nutritional Intervention

Interventions

  • OtherExercise Training

    Virtually supervised exercise training for four weeks prior to cystectomy

  • Dietary supplementNutritional 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

05

What researchers measure

Primary outcomes

  1. Total days hospitalized within 30-days of surgery

    This is the total number of days within 30 days after bladder removal surgery, that a patient is hospitalized.

    Time frame: 60 months

  2. Length of stay

    This is the total length of stay in days after bladder removal surgery

    Time frame: 60 months

  3. Number and type of minor and major complications

    This is the number and types of major and minor complications which occur post bladder removal surgery

    Time frame: 60 months

  4. Discharge disposition

    This is the disposition of the patient at discharge or when the patient is released from the hospital.

    Time frame: 60 months

  5. Readmissions

    This is the number of times a patient that was discharged come back to the hospital for any issue related to their bladder removal surgery.

    Time frame: 60 months

06

Study locations

2 of 2 sites recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05715684
Lead sponsor
Brigham and Women's Hospital
Collaborators
Abbott Nutrition
Responsible party
Matthew Mossanen, MD, MPH (Urologic Surgeon, Brigham and Women's Hospital) — Principal investigator
First posted
Feb 8, 2023
Start date
Mar 1, 2023
Primary completion
Dec 27, 2026 (estimated)
Completion
Dec 25, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Matthew Mossanen, MD, MPH
Contact
mmossanen@bwh.harvard.edu
617-732-6384
Nnamdi Onochie
Contact
nnamdi_onochie@dfci.harvard.edu
6175258753

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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