Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning



Status:Recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:55 - 85
Updated:2/27/2019
Start Date:February 22, 2019
End Date:February 21, 2022
Contact:Rachel Minkin, MS
Email:rminkin@mcw.edu
Phone:414-955-1922

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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.

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 "prehabiliative" 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.

Inclusion Criteria:

- Be between the ages of 55-85

- Have a diagnosis of non-metastatic colon cancer

- Be scheduled for curative resection of non-metastatic colon cancer

- Have a 6MWT 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

- MI during previous month.
We found this trial at
1
site
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-5619
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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from
Milwaukee, WI
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