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Colon CancerPrehabNCT03853473

Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

A study testing Remote Ischemic Preconditioning in people with Colon Cancer and Fragility, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Colon Cancer, Fragility, Prehabilitation
What is being tested?
Remote Ischemic Preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
22 Feb 2019to 1 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

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.

Read the 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.

Being tested
Remote Ischemic Preconditioning
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Ischemic PreconditioningProcedure or surgery

    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.

Study groups in NCT03853473
Study groupRoleWhat they receive
Standard of CareNo interventionStudy participants will receive standard of care.
Remote Ischemic PreconditioningExperimentalStudy participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery.
Receives: Procedure: Remote Ischemic Preconditioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Pre-Surgery

Secondary outcomes (8)
  1. 10 Meter Walk Test (Pre Surgery)

    The investigators will compare the speed study participants walk over 10 meters in the pre-surgical period as a secondary measure of frailty.

    Measured: Pre-Surgery

  2. Timed Up and Go (Pre Surgery)

    The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) in the pre-surgical period as a secondary measure of frailty.

    Measured: Years 1-3

  3. Hand Grip Strength (Pre Surgery)

    The investigators will compare handgrip strength in the presurgical period as a secondary measure of frailty.

    Measured: Years 1-3

  4. 6 Minute Walk Test Distance (Post Surgery)

    The investigators will compare the distance study participants walk in 6-minutes 4-weeks post-surgery as a secondary outcome of surgical recovery.

    Measured: Years 1-3

  5. 10 Meter Walk Test (Post Surgery)

    The investigators will compare the speed study participants walk 10 meters 4-weeks post-surgery as a secondary outcome of surgical recovery.

    Measured: Years 1-3

  6. Timed Up and Go (Post Surgery)

    The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) 4-weeks post surgery as a secondary measure of surgical recovery.

    Measured: Years 1-3

  7. Hand Grip Strength (Post Surgery)

    The investigators will compare handgrip strength 4-weeks post surgery as a secondary measure of surgical recovery.

    Measured: Years 1-3

  8. Intraoperative Blood Pressure Variability

    The investigators will measure the variability of blood pressure during the intraoperative period using the anesthetic record.

    Measured: Years 1-3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2019
  2. Study start22 Feb 2019
  3. Primary completion1 Feb 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, Randomized, Blinded, Controlled Trial
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03853473
Sponsor's protocol ID
PRO00032510
Other IDs
1R21AG062933
Acronym
Prehab
Status last verified
Sep 2024
First submitted
22 Feb 2019
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Remote Ischemic Preconditioning in people with Colon Cancer and Fragility, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walk Test Distance (Pre Surgery) (time frame: Pre-Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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