Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

NCT03853473 | Completed Results

• 2 other identifiers: PRO000325101R21AG062933
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This project will examine the efficacy of a simple, cost-effective, non-invasive intervention, called remote ischemic preconditioning (RIPC), to reduce frailty in pre-surgical, frail, elderly patients with colon cancer. The investigators hypothesize that RIPC will reduce frailty in the pre-surgical period (as assessed by distance walked during the 6-minute walk test), improve functional capacity 4-weeks postoperatively, and reduce intraoperative blood pressure variability. If successful, future studies will examine the efficacy of RIPC to improve surgical outcomes in frail cancer patients.

Conditions

Colon Cancer; Fragility; Prehabilitation; Surgery

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walk Test Distance (Pre Surgery)

  The investigators will compare the distance study participants can walk in 6 minutes in the pre-surgical period as a measure of frailty.

  Pre-Surgery

Secondary Outcomes (8)

• 10 Meter Walk Test (Pre Surgery)

  Pre-Surgery

• Timed Up and Go (Pre Surgery)

  Years 1-3

• Hand Grip Strength (Pre Surgery)

  Years 1-3

• 6 Minute Walk Test Distance (Post Surgery)

  Years 1-3

• 10 Meter Walk Test (Post Surgery)

  Years 1-3

Other Outcomes (3)

• Number of Hours of Rehabilitation

  Years 1-3

• All Cause Mortality

  Years 1-3

• Length of Hospital Stay

  Years 1-3

Study Arms (2)

Standard of Care

NO INTERVENTION

Study participants will receive standard of care.

Remote Ischemic Preconditioning

EXPERIMENTAL

Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.

Procedure: Remote Ischemic Preconditioning

Interventions

Remote Ischemic Preconditioning PROCEDURE

Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.

Remote Ischemic Preconditioning

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 55-85
• Have a positive diagnosis of colon cancer or suspected colon cancer based on pathology report
• Be scheduled for curative resection of non-metastatic colon cancer
• Have a 6-Minute Walk Test distance ≤80% of predicted value based on age and sex.

You may not qualify if:

• Condition which prevents walking
• Any condition in which compression of the arm or transient ischemia is contraindicated (e.g. wounds in the arm)
• Neurodegenerative disorder
• Unstable angina in previous month
• Myocardial infarction during previous month.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Matthew J. Durand, Ph.D., Principal Investigator
• Organization: Medical College of Wisconsin

mdurand@mcw.edu

414-955-5619

Study Officials

• Matthew J Durand, Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Julie K Freed, MD, Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomized by the study statistician to receive either the intervention (remote ischemic conditioning) or standard of care. Participants cannot be blinded using this model.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, Randomized, Blinded, Controlled Trial

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: February 22, 2019
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)