Clinical trial NCT03853473: Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
Official title: Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Fragility
Prehabilitation
Surgery
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-02-25
Enrollment: 17
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Blinded, Controlled Trial
Primary purpose: TREATMENT

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.

Detailed description: Remote ischemic preconditioning (RIPC) was first described three decades ago as an intervention to protect vital organs from ischemic injury. RIPC occurs when a tissue is made transiently ischemic (5 minutes) for repeated bouts (5 times) prior to the longer ischemic insult. Recently it has been shown exercise performance and motor function are improved in young, healthy individuals when RIPC is performed on the arm or leg using a simple blood pressure cuff to occlude blood flow to the limb. The application of RIPC to individuals with reduced functional capacity, however, is largely unexplored. The study team was the first to apply RIPC to chronic stroke survivors with reduced physical function, and two weeks of RIPC increases walking speed, paretic muscle strength and fatigue resistance. Advanced age and cancer are both dramatic accelerators of frailty and frail patients have poor surgical outcomes. Therefore, the investigators propose to apply this non-invasive, simple intervention as a "prehabilitation" therapy to elderly patients with colon cancer during the perioperative period. The investigators will enroll 96 colon cancer patients aged 55-85 who are ≥17 days prior to scheduled curative resection of colon cancer. After study enrollment, all participants will perform the six-minute walk test as a measure of frailty. Participants will then be randomized to receive either RIPC on their upper, non-dominant arm daily for 14 days prior to surgery, or to receive standard of care (no intervention). After 14 days of either RIPC or no intervention, the 6-minute walk test will be re-assessed within 48 hours of surgery. The primary study outcome will be the difference in six-minute walk distance (in meters) between patients in the RIPC group vs. those in the standard of care group following the two-week pre-operative intervention period (Aim 1). The investigators hypothesize that patients in the RIPC group will walk further during the six-minute walk test than those in the standard of care group due to the well-defined effects of RIPC to improve athletic performance, cardiovascular function, and strength in healthy individuals. A secondary study outcome will be the difference in six-minute walk test distance between the RIPC and standard of care group 4-weeks postoperatively (Aim 2). The investigators hypothesize that patients in the RIPC group will have more rapid recovery from surgery, which would be evidenced by increased walking endurance post-operatively. Another secondary study outcome will be the amount of intraoperative blood pressure variability (time systolic pressure is above or below 135 mmHg or 95 mmHg, respectively) between the RIPC and control groups (Aim 3). The investigators hypothesize that RIPC will reduce intraoperative blood pressure variability due to the well described effects of RIPC to improve systemic vascular function. Future larger studies will examine the effects of RIPC prehabilitation on surgical outcomes such as length of hospital stay and all-cause mortality in frail, elderly patients with colon cancer as well as other patient cohorts with reduced functional capacity.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 6 Minute Walk Test Distance (Pre Surgery)
timeFrame: Pre-Surgery
Secondary outcomes:
measure: 10 Meter Walk Test (Pre Surgery)
timeFrame: Pre-Surgery
measure: Timed Up and Go (Pre Surgery)
timeFrame: Years 1-3
measure: Hand Grip Strength (Pre Surgery)
timeFrame: Years 1-3
measure: 6 Minute Walk Test Distance (Post Surgery)
timeFrame: Years 1-3
measure: 10 Meter Walk Test (Post Surgery)
timeFrame: Years 1-3
measure: Timed Up and Go (Post Surgery)
timeFrame: Years 1-3
measure: Hand Grip Strength (Post Surgery)
timeFrame: Years 1-3
measure: Intraoperative Blood Pressure Variability
timeFrame: Years 1-3
Other outcomes:
measure: Number of Hours of Rehabilitation
timeFrame: Years 1-3
measure: All Cause Mortality
timeFrame: Years 1-3
measure: Length of Hospital Stay
timeFrame: Years 1-3
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Matthew J Durand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Julie K Freed, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: