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Completed

NCT Number: NCT02648880

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.

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Key information

Conditions

Pancreatic Cancer Behavior Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Motor Activity Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in 400-meter Walk Time

    Time frame: 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 outcomes

  1. Change in Body Composition

    Time frame: 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.

  2. Change in Gait Speed

    Time frame: 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.

  3. Change in Timed Up and Go

    Time frame: 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.

  4. Change in Stair Climb Test

    Time frame: 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.

  5. Change in Single Limb Stance

    Time frame: 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.

  6. Change in 30 Second Sit-to-Stand

    Time frame: 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.

  7. Change in Grip Strength

    Time frame: 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.

  8. Change in Average Daily Step Count

    Time frame: 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.

  9. Change in Wellness

    Time frame: 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.

  10. Change in Health-related Quality of Life

    Time frame: 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.

  11. Change in Perceived Fatigue

    Time frame: 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.

  12. Change in Anxiety

    Time frame: 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.

  13. Change in Perceived Stress

    Time frame: 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.

  14. Resting Heart Rate Variability

    Time frame: 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.

  15. Heart Rate Variability Response to Physiologic Challenge

    Time frame: 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).

  16. Heart Rate Variability Response to Mental Stressor

    Time frame: 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).

  17. Heart Rate Variability Response to a Cancer-specific Mental Stressor

    Time frame: 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).

  18. Change in C-reactive Protein

    Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

    Serum C-reactive protein will be assessed from blood draws.

  19. Change in Interleukin-6

    Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

    Serum interleukin-6 will be assessed from blood draws.

  20. Change in Soluble Tumor-necrosis Factor Receptor 1

    Time frame: 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.

  21. Change in Interleukin-10

    Time frame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative

    Serum interleukin-10 will be assessed from blood draws.

  22. Determination of Hospital Length of Stay

    Time frame: 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.

  23. Determination of Hospital Readmission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Jan 7, 2016
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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