Preoperative Exercise in Pancreatic Cancer

Not Applicable

Completed

Conditions: Pancreatic Cancer

Interventions: Other: Standard Care
Behavioral: Exercise program

Registration Number: NCT02648880

Lead Sponsor: University of Colorado, Denver

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	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.
Exercise Group	Standard Care	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 Group	Exercise program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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.
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).
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 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 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 Interleukin-10	Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative	Serum interleukin-10 will be assessed from blood draws.
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 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 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.
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 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.
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 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.
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.