The Effects of a Preoperative Exercise Intervention During Neoadjuvant Therapy in Patients With Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in 400-meter Walk Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Pregnancy
- •Second cancer diagnosis at the time of enrollment
结局指标
主要结局
Change in 400-meter Walk Time
时间窗: 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.
次要结局
- Change in Body Composition(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Gait Speed(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Timed Up and Go(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Average Daily Step Count(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Wellness(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Heart Rate Variability Response to Mental Stressor(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Single Limb Stance(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in 30 Second Sit-to-Stand(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Anxiety(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Stair Climb Test(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Interleukin-10(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Grip Strength(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Health-related Quality of Life(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Perceived Stress(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Determination of Hospital Readmission(30 days after hospital discharge)
- Determination of Hospital Length of Stay(30 days after hospital discharge)
- Change in Perceived Fatigue(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Resting Heart Rate Variability(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Heart Rate Variability Response to Physiologic Challenge(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Heart Rate Variability Response to a Cancer-specific Mental Stressor(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in C-reactive Protein(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Interleukin-6(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)
- Change in Soluble Tumor-necrosis Factor Receptor 1(Baseline, Pre-operative (within the 2 weeks prior to surgery), 6 weeks postoperative)