Bladder CancerPrehabNCT05715684
Patient-Centered Surgical Prehabilitation
A study testing Exercise Training and Nutritional Intervention in people with Bladder Cancer and Cystectomy, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Cystectomy
- What is being tested?
- Exercise Training and Nutritional Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2023to 25 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.)
- 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
- 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 study procedures
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Matthew Mossanen, MD, (617) 732-6384, mmossanen@bwh.harvard.edu
Matthew Mossanen, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Matthew Mossanen, MD, 617-732-6384, mmossanen@bwh.harvard.edu
Matthew Mossanen, MD
About this study
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
- Conditions
- Bladder Cancer, Cystectomy
- Being tested
- Exercise Training, Nutritional Intervention
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Virtually supervised exercise training for four weeks prior to cystectomy
Nutritional InterventionDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment Plan | Other | This is the main arm of the study in which all 25 anticipated participants will be enrolled into. Receives: Other: Exercise Training; Dietary Supplement: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
Length of stay
This is the total length of stay in days after bladder removal surgery
Measured: 60 months
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
Measured: 60 months
Discharge disposition
This is the disposition of the patient at discharge or when the patient is released from the hospital.
Measured: 60 months
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Mar 2023
- Primary completion27 Dec 2026 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Principal investigator, Matthew Mossanen, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715684
- Sponsor's protocol ID
- 22-329
- Acronym
- Prehab
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Surgical Prehabilitation
- ClinicalTrials.gov ID
- NCT05715684
- Acronym / sponsor ID
- Prehab / 22-329
- Conditions
- Bladder Cancer, Cystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 25 Dec 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard treatment Plan | Other | Other: Exercise Training, Dietary Supplement: Nutritional InterventionThis is the main arm of the study in which all 25 anticipated participants will be enrolled into. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingVirtually supervised exercise training for four weeks prior to cystectomy | Other | Standard treatment Plan |
| Nutritional InterventionPatients 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 | Dietary supplement | Standard treatment Plan |
Primary outcome
Total days hospitalized within 30-days of surgery
Time frame: 60 months
This is the total number of days within 30 days after bladder removal surgery, that a patient is hospitalized.
Length of stay
Time frame: 60 months
This is the total length of stay in days after bladder removal surgery
Number and type of minor and major complications
Time frame: 60 months
This is the number and types of major and minor complications which occur post bladder removal surgery
Discharge disposition
Time frame: 60 months
This is the disposition of the patient at discharge or when the patient is released from the hospital.
Readmissions
Time frame: 60 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Nutritional Intervention in people with Bladder Cancer and Cystectomy, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Mossanen, MD, MPH (617-732-6384, mmossanen@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total days hospitalized within 30-days of surgery (time frame: 60 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.