Patient-Centered Surgical Prehabilitation

NCT ID: NCT05715684

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-12-25

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard treatment Plan

This is the main arm of the study in which all 25 anticipated participants will be enrolled into.

Group Type: OTHER

Exercise Training

Intervention Type: OTHER

Virtually supervised exercise training for four weeks prior to cystectomy

Nutritional Intervention

Intervention Type: DIETARY_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

Interventions

Exercise Training

Virtually supervised exercise training for four weeks prior to cystectomy

Intervention Type: OTHER

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Matthew Mossanen, MD

Urologic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Mossanen, MD, MPH

Role: CONTACT

mmossanen@bwh.harvard.edu

617-732-6384

Nnamdi Onochie

Role: CONTACT

nnamdi_onochie@dfci.harvard.edu

6175258753

Facility Contacts

Matthew Mossanen, MD

Role: primary

mmossanen@bwh.harvard.edu

617-732-6384

Matthew Mossanen, MD

Role: primary

mmossanen@bwh.harvard.edu

617-732-6384

Other Identifiers

22-329

Identifier Type: -

Identifier Source: org_study_id