N/A
N=3
Preoperative Exercise in Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02648880 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in 400-meter Walk Time — 212.7; 194.3; 204 s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise program (Behavioral); Standard Care (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 400-meter Walk Time |
212.7; 194.3; 204 | — |
| SECONDARY Change in Body Composition |
— | — |
| SECONDARY Change in Gait Speed |
— | — |
| SECONDARY Change in Timed Up and Go |
— | — |
| SECONDARY Change in Stair Climb Test |
— | — |
| SECONDARY Change in Single Limb Stance |
— | — |
| SECONDARY Change in 30 Second Sit-to-Stand |
— | — |
| SECONDARY Change in Grip Strength |
— | — |
| SECONDARY Change in Average Daily Step Count |
— | — |
| SECONDARY Change in Wellness |
— | — |
| SECONDARY Change in Health-related Quality of Life |
— | — |
| SECONDARY Change in Perceived Fatigue |
— | — |
| SECONDARY Change in Anxiety |
— | — |
| SECONDARY Change in Perceived Stress |
— | — |
| SECONDARY Resting Heart Rate Variability |
— | — |
| SECONDARY Heart Rate Variability Response to Physiologic Challenge |
— | — |
| SECONDARY Heart Rate Variability Response to Mental Stressor |
— | — |
| SECONDARY Heart Rate Variability Response to a Cancer-specific Mental Stressor |
— | — |
| SECONDARY Change in C-reactive Protein |
— | — |
| SECONDARY Change in Interleukin-6 |
— | — |
| SECONDARY Change in Soluble Tumor-necrosis Factor Receptor 1 |
— | — |
| SECONDARY Change in Interleukin-10 |
— | — |
| SECONDARY Determination of Hospital Length of Stay |
— | — |
| SECONDARY Determination of Hospital Readmission |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02648880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.