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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group | Experimental | 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. |
|
| Standard Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Composition | Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat. | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative |
| Change in Gait Speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Jankowski, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | United States |
This is a small, non-FDA Regulated pilot study of an exercise intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One participant did not receive surgery and was excluded from the postoperative timepoint. | Posted | Mean | Full Range | s | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative |
|
Approximately 6 months. From baseline assessment through 6 weeks after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Marker | University of Colorado | 3037240819 | ryan.marker@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 20, 2016 | Oct 7, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Standard Care | Other | 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. |
|
Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 30 days after hospital discharge |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Body Composition | Assessment of physical fitness. Dual-energy x-ray absorptiometry (DXA) will assess lean muscle mass and body fat. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Gait Speed | Participant gait speed will be determined on a 10 meter course for both fast and self-selected paces. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Stair Climb Test | Participants are timed as they ascend and descend one flight of stairs. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Single Limb Stance | Participants are timed on how long they can balance on one leg. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in 30 Second Sit-to-Stand | The number of times a participant can rise from a chair in 30 seconds is counted. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Grip Strength | The maximum force the participant can produce separately with both hands, assessed by grip dynamometry, is measured. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Wellness | The Colorado Comprehensive Wellness Assessment, a survey, will be administered to assess eight domains of wellness. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Health-related Quality of Life | The Functional Assessment of Cancer Therapy - General Form (FACT-G), a survey, will be administered. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Perceived Fatigue | Perceived fatigue will be assessed by the Revised Piper Fatigue Scale, a survey. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Anxiety | Changes in state and trait anxiety will be assessed with the Spielberger State-Trait Anxiety Index. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Perceived Stress | Changes in perceived stress will be assessed with the Perceived Stress Scale. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Resting Heart Rate Variability | Heart rate variability will be assessed from electrocardiography (ECG) obtained during a 5 min rest period. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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). | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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). | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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). | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in C-reactive Protein | Serum C-reactive protein will be assessed from blood draws. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Interleukin-6 | Serum interleukin-6 will be assessed from blood draws. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Soluble Tumor-necrosis Factor Receptor 1 | Soluble tumor-necrosis factor receptor 1 will be assessed from blood draws. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| Secondary | Change in Interleukin-10 | Serum interleukin-10 will be assessed from blood draws. | Not Posted | Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative | Participants |
| 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. | Not Posted | 30 days after hospital discharge | Participants |
| 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. | Not Posted | 30 days after hospital discharge | Participants |
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |