An interventional study of Exercise program and Standard Care in Pancreatic Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
The purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. Preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. The outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. This investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. Possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. These measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. Changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.
This study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. This allows for a known, preoperative window long enough to provide an effective exercise intervention. The exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function.
The study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. All participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. Participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.
This study's enrollment of 3 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will complete an exercise program in addition to standard care. Participants will start the exercise program within four weeks of their diagnosis and decision to undergo neoadjuvant treatment and continue until surgery. Participants will be encouraged to complete three sessions per week for at least eight weeks during neoadjuvant therapy. Exercise intensity, components, and time will be recorded for each exercise session. Participants will schedule their sessions with the exercise specialists administering the program, typically taking place between 8AM and 4PM, Monday through Friday.
Behavioral: Exercise program · Other: Standard Care
Participants in the Standard Care group will receive no exercise intervention, but will continue to receive standard follow-ups, treatments and services from their oncology team.
Other: Standard Care
Individual exercise sessions in this program implement a "whole body" approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation.
The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
Change in 400-meter Walk Time
Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Body Composition
Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Gait Speed
Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Timed Up and Go
Participants are timed as they rise from a chair, walk 3 meters, turn around, and return to the chair and sit.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Stair Climb Test
Participants are timed as they ascend and descend one flight of stairs.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Single Limb Stance
Participants are timed on how long they can balance on one leg.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in 30 Second Sit-to-Stand
The number of times a participant can rise from a chair in 30 seconds is counted.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Grip Strength
The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Average Daily Step Count
The average step count for a minimum of 3 days over a 7 day period will be assessed with accelerometry.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Wellness
The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Health-related Quality of Life
The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Fatigue
Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Anxiety
Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Perceived Stress
Changes in perceived stress will be assessed with the Perceived Stress Scale.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Resting Heart Rate Variability
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Physiologic Challenge
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a physiologic challenge (orthostatic stress: chair rise).
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to Mental Stressor
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a mental challenge (Stroop Task).
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Heart Rate Variability Response to a Cancer-specific Mental Stressor
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a cancer-specific mental challenge (Cancer-Specific Stroop Task).
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in C-reactive Protein
Serum C-reactive protein will be assessed from blood draws.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-6
Serum interleukin-6 will be assessed from blood draws.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Soluble Tumor-necrosis Factor Receptor 1
Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Change in Interleukin-10
Serum interleukin-10 will be assessed from blood draws.
Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Determination of Hospital Length of Stay
At 30 days after discharge from the hospital, a medical record review will be conducted to determine the number of days participants were in the hospital after surgery.
Time frame: 30 days after hospital discharge
Determination of Hospital Readmission
At 30 days after discharge from the hospital, a medical record review will be conducted to determine whether participants were readmitted to the hospital for an unplanned surgical complication in the 30 days following hospital discharge.
Time frame: 30 days after hospital discharge
| Milestone | Exercise Group |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace.
| s | Exercise Group |
|---|---|
| Baseline | 212.7 (211 to 214) |
| Pre-operative | 194.3 (188 to 205) |
| Postoperative | 204 (195 to 213) |
Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat.
Results for this outcome have not been posted.
Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces.
Results for this outcome have not been posted.
Participants are timed as they rise from a chair, walk 3 meters, turn around, and return to the chair and sit.
Results for this outcome have not been posted.
Participants are timed as they ascend and descend one flight of stairs.
Results for this outcome have not been posted.
Participants are timed on how long they can balance on one leg.
Results for this outcome have not been posted.
The number of times a participant can rise from a chair in 30 seconds is counted.
Results for this outcome have not been posted.
The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured.
Results for this outcome have not been posted.
The average step count for a minimum of 3 days over a 7 day period will be assessed with accelerometry.
Results for this outcome have not been posted.
The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness.
Results for this outcome have not been posted.
The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered.
Results for this outcome have not been posted.
Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey.
Results for this outcome have not been posted.
Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index.
Results for this outcome have not been posted.
Changes in perceived stress will be assessed with the Perceived Stress Scale.
Results for this outcome have not been posted.
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period.
Results for this outcome have not been posted.
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a physiologic challenge (orthostatic stress: chair rise).
Results for this outcome have not been posted.
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a mental challenge (Stroop Task).
Results for this outcome have not been posted.
Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period, and changes in response to a cancer-specific mental challenge (Cancer-Specific Stroop Task).
Results for this outcome have not been posted.
Serum C-reactive protein will be assessed from blood draws.
Results for this outcome have not been posted.
Serum interleukin-6 will be assessed from blood draws.
Results for this outcome have not been posted.
Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws.
Results for this outcome have not been posted.
Serum interleukin-10 will be assessed from blood draws.
Results for this outcome have not been posted.
At 30 days after discharge from the hospital, a medical record review will be conducted to determine the number of days participants were in the hospital after surgery.
Results for this outcome have not been posted.
At 30 days after discharge from the hospital, a medical record review will be conducted to determine whether participants were readmitted to the hospital for an unplanned surgical complication in the 30 days following hospital discharge.
Results for this outcome have not been posted.
Collected over Approximately 6 months. From baseline assessment through 6 weeks after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Exercise Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Exercise Group |
|---|---|
| Female | 1 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Exercise Group |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Exercise Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Exercise Group |
|---|---|
| United States | 3 |
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Plan to share: No — This is a small, non-FDA Regulated pilot study of an exercise intervention.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver