Clinical trial NCT02648880: Preoperative Exercise in Pancreatic Cancer
Official title: The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Exercise
Physical Activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 400-meter Walk Time
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
Secondary outcomes:
measure: Change in Body Composition
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Gait Speed
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Timed Up and Go
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Stair Climb Test
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Single Limb Stance
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in 30 Second Sit-to-Stand
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Grip Strength
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Average Daily Step Count
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Wellness
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Health-related Quality of Life
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Perceived Fatigue
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Anxiety
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Perceived Stress
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Resting Heart Rate Variability
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Heart Rate Variability Response to Physiologic Challenge
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Heart Rate Variability Response to Mental Stressor
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Heart Rate Variability Response to a Cancer-specific Mental Stressor
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in C-reactive Protein
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Interleukin-6
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Soluble Tumor-necrosis Factor Receptor 1
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Change in Interleukin-10
timeFrame: Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative
measure: Determination of Hospital Length of Stay
timeFrame: 30 days after hospital discharge
measure: Determination of Hospital Readmission
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Health and Wellness Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Catherine Jankowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: