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2016-05-10
2017-01-20
2021-01
3
NCT02648880
University of Colorado, Denver
University of Colorado, Denver
INTERVENTIONAL
Preoperative Exercise in Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-12-29 | 2021-10-07 | 2021-11-29 |
2016-01-06 | 2021-11-29 | 2021-11-30 |
2016-01-07 | 2021-11-30 | 2021-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 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 e | BEHAVIORAL: Exercise program
OTHER: Standard Care
|
| ACTIVE_COMPARATOR: 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
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
