Preoperative Exercise in Pancreatic Cancer

The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Behavioral: Exercise program; Other: Standard Care

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Health and Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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 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; 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.; Other: 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2016
• Primary Completion (Actual): January 20, 2017
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 15-2266.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small, non-FDA Regulated pilot study of an exercise intervention.