Preoperative Exercise in Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Exercise program; Standard Care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; Physical Activity