Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC)
详细描述
Our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other GI or Gyn primary tumor
- •Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
- •Subjects who are explored but found to be unresectable will be included.
- •Male or female.
- •Patients should be age 18 or above.
- •Surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation
排除标准
- •Patients who do not consent to surgery.
- •Patients who require urgent surgery, sooner than 6 weeks
- •Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
- •Patients not fluent in English
- •Pregnant women
- •Prisoners
- •Patients with Cognitive Impairment
研究组 & 干预措施
Exercise Group
Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
干预措施: Home-based Exercise Program Prior to CRS-HIPEC (Behavioral)
Education Group
Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded.
干预措施: Exercise Education (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 1 year
Rate of enrollment into this trial
Feasibility of doing exercises
时间窗: 2 months
The percent of exercises completed by subjects
次要结局
- Quality of Life after CRS-HIPEC(1 year)
- 30-day Complication(1 month)
研究者
Colette Pameijer
Professor, Department of Surgery
Milton S. Hershey Medical Center