Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of participants to complete prehabilitation program
研究概览
简要总结
The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)
详细描述
This research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation.
The names of the study interventions involved in this study are:
- Exercise Intervention
- Nutrition Intervention
The research study procedures include: screening for eligibility, study evaluations, and follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Adults age 18 years or older.
- •Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN).
- •Planning to undergo TNT at MGH.
- •Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy.
- •Planning to undergo surgical resection of PDAC at MGH.
- •Verbal fluency in English.
排除标准
- •Metastatic disease.
- •Previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years.
- •Known history of cognitive or psychologic impairment.
- •Known history of physical impairment such as immobility, use of walking aids, or required wheelchair use.
- •Known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia).
- •Known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (COPD) defined as FEV1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen.
- •Known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (NYHA Class IV), and/or myocardial infarction within the last 6 months.
- •Inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.
研究组 & 干预措施
Multimodal Prehabilitation Program
Pretreatment exercise program and nutrition program
-The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
干预措施: Exercise Program (Behavioral)
Multimodal Prehabilitation Program
Pretreatment exercise program and nutrition program
-The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
干预措施: Nutrition Program (Behavioral)
结局指标
主要结局
Number of participants to complete prehabilitation program
时间窗: 1 year
At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.
次要结局
未报告次要终点
研究者
Motaz Qadan
Principal Investigator
Massachusetts General Hospital