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.
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
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.
- Conditions
- Colon Cancer, Fragility, Prehabilitation, Surgery
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Remote Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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.
- First posted25 Feb 2019
- Study start22 Feb 2019
- Primary completion1 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Matthew J. Durand, Medical College of Wisconsin
- Investigators
- Matthew J Durand, Ph.D., Principal investigator, Medical College of WisconsinJulie K Freed, MD, Ph.D., Principal investigator, Medical College of Wisconsin
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
- ClinicalTrials.gov ID
- NCT03853473
- Acronym / sponsor ID
- Prehab / PRO00032510
- Conditions
- Colon Cancer, Fragility, Prehabilitation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Blinded, Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Study participants will receive standard of care. |
| Remote Ischemic Preconditioning | Experimental | Procedure: Remote Ischemic PreconditioningStudy participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic PreconditioningRemote 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. | Procedure or surgery | Remote Ischemic Preconditioning |
Primary outcome
6 Minute Walk Test Distance (Pre Surgery)
Time frame: 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.
8 secondary outcomes
10 Meter Walk Test (Pre Surgery)
Time frame: Pre-Surgery
Timed Up and Go (Pre Surgery)
Time frame: Years 1-3
Hand Grip Strength (Pre Surgery)
Time frame: Years 1-3
6 Minute Walk Test Distance (Post Surgery)
Time frame: Years 1-3
10 Meter Walk Test (Post Surgery)
Time frame: Years 1-3
Timed Up and Go (Post Surgery)
Time frame: Years 1-3
Hand Grip Strength (Post Surgery)
Time frame: Years 1-3
Intraoperative Blood Pressure Variability
Time frame: Years 1-3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Durand, Ph.D. principal investigator
Medical College of Wisconsin
Julie K Freed, MD, Ph.D. principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
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.