Pancreatic Cancer
Conditions
Keywords
Exercise, Physical Activity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALExercise program
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.
OTHERStandard Care
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.
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Recent (\< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma * Prescription to receive neoadjuvant therapy and surgery, * Age 21 to 80 years old, * Physician clearance to participate in exercise program.
Exclusion criteria
* Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries * Advanced rheumatoid arthritis * Widespread chronic pain conditions such as fibromyalgia * Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen * Known cardiovascular disease or new cardiac event in last 6 months * Diabetes * Pregnancy * Second cancer diagnosis at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 400-meter Walk Time | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Assessment of physical fitness and function. Participants are timed while walking 400 meters at a fast, but safe, pace. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces. |
| Change in Timed Up and Go | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants are timed as they rise from a chair, walk 3 meters, turn around, and return to the chair and sit. |
| Change in Stair Climb Test | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants are timed as they ascend and descend one flight of stairs. |
| Change in Single Limb Stance | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants are timed on how long they can balance on one leg. |
| Change in 30 Second Sit-to-Stand | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | The number of times a participant can rise from a chair in 30 seconds is counted. |
| Change in Grip Strength | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured. |
| Change in Average Daily Step Count | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | The average step count for a minimum of 3 days over a 7 day period will be assessed with accelerometry. |
| Change in Wellness | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness. |
| Change in Health-related Quality of Life | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered. |
| Change in Perceived Fatigue | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey. |
| Change in Anxiety | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index. |
| Change in Body Composition | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat. |
| Resting Heart Rate Variability | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period. |
| Heart Rate Variability Response to Physiologic Challenge | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | 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). |
| Heart Rate Variability Response to Mental Stressor | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | 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). |
| Heart Rate Variability Response to a Cancer-specific Mental Stressor | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | 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). |
| Change in C-reactive Protein | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Serum C-reactive protein will be assessed from blood draws. |
| Change in Interleukin-6 | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Serum interleukin-6 will be assessed from blood draws. |
| Change in Soluble Tumor-necrosis Factor Receptor 1 | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws. |
| Change in Interleukin-10 | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Serum interleukin-10 will be assessed from blood draws. |
| Determination of Hospital Length of Stay | 30 days after hospital discharge | 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. |
| Determination of Hospital Readmission | 30 days after hospital discharge | 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. |
| Change in Perceived Stress | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Changes in perceived stress will be assessed with the Perceived Stress Scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Group 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.
Exercise program: 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.
Standard Care: 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Exercise Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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
Population: One participant did not receive surgery and was excluded from the postoperative timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Group | Change in 400-meter Walk Time | Baseline | 212.7 s |
| Exercise Group | Change in 400-meter Walk Time | Pre-operative | 194.3 s |
| Exercise Group | Change in 400-meter Walk Time | Postoperative | 204 s |
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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