Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
Condition: Colon Cancer; Fragility; Prehabilitaiton; Surgery
MeSH terms: Colonic Neoplasms
Study type: Interventional

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 "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.
    

Intervention name(s): Remote Ischemic Preconditioning
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Blinded, Controlled Trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment