Preoperative Exercise in Pancreatic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 12/5/2018 |
| Start Date: | May 10, 2016 |
| End Date: | October 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Aurora, Colorado 80022
Phone: 303-724-9601
Click here to add this to my saved trials
