Patient-Centered Surgical Prehabilitation

Bladder Cancer Clinical Trial

— Prehab  

Official title:

Patient-Centered Surgical Prehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715684
• Other study ID #: 22-329
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 25, 2027

Study information

• Verified date: March 2023
• Source: Dana-Farber Cancer Institute
• Contact: Matthew Mossanen, MD, MPH
• Phone: 617-732-6384
• Email: mmossanen[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 25, 2027
• Est. primary completion date: December 27, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Bladder Cancer
• Cystectomy
• Urinary Bladder Neoplasms

Intervention

Other:
• Exercise Training
Virtually supervised exercise training for four weeks prior to cystectomy

Dietary Supplement:
• Nutritional 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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 months
Primary	Length of stay	This is the total length of stay in days after bladder removal surgery	60 months
Primary	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	60 months
Primary	Discharge disposition	This is the disposition of the patient at discharge or when the patient is released from the hospital.	60 months
Primary	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.	60 months