Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in functional walking capacity as measured by the six-minute walk test (6MWT)
研究概览
简要总结
Major surgery is a stressful procedure; good recovery after surgery is important to patients and their doctors. Studies done at the McGill University Health Centre (MUHC) with cancer patients awaiting surgery have shown that exercise combined with simple diet recommendations (which may include a supplement) and relaxation techniques before surgery helped speed up the ability to resume walking after surgery.
These results have made the investigators aware that exercise and good nutrition are as important before surgery as they are after surgery; while it is common practice to start strengthening the body after surgery (rehabilitation), there may be some advantage to begin this process before surgery (prehabilitation).
The purpose of this study is to see if the following program, either before or after surgery, can help patients recover from liver, pancreas or bile duct surgery:
- Exercise that may help participants move and breath better,
- Nutrition advice and a supplement to make participants strong,
- Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery
The investigators will see if following this program will have an effect on participants' ability to walk before and after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis or suspicion of either hepatobiliary or pancreatic cancer (primary or metastatic)
- •Must be scheduled for surgical resection between 4-6 weeks of recruitment
排除标准
- •Persons with American Society of Anesthesiologists (ASA) health status class 4-5
- •Comorbid medical, physical and mental conditions (eg: dementia, disabling orthopedic and neuromuscular disease, psychosis)
- •Cardiac abnormalities
- •Severe end-organ disease such as cardiac failure, chronic obstructive pulmonary failure and hepatic failure (alanine aminotransferase and aspartate aminotransferase >50% over the normal range)
- •Morbid obesity (BMI >40)
- •Anemia (hematocrit <30 %)
- •Other conditions interfering with the ability to perform exercise at home or to complete the testing procedures
- •Poor English or French comprehension
结局指标
主要结局
Change in functional walking capacity as measured by the six-minute walk test (6MWT)
时间窗: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 meter stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines. They are allowed to rest during the test if needed, but this time is included in the 6 minutes. Reference equations are available for calculating percent of age- and gender-specific norm.
次要结局
- Change in handgrip strength(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Postoperative complications(4 weeks post-operatively)
- Fatigue - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- 30-second arm curl test(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Assessment of food intake and change over study period(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Nutritional status - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Body mass index - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Heart rate - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Timed up and go test(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- 30-second sit to stand test(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Change in body composition(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Perioperative data(7 days post-operatively)
- Height(Baseline)
- The Edmonton Symptom Assessment System (ESAS) - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Blood pressure - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Health-related quality of life (HRQL) - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Physical activity level - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
- Weight - assessment of change over time(Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative)
研究者
Antonio Vigano
Attending Physician, Supportive and Palliative Care Division; Director, Cancer Rehabilitation (CARE) Program; Director, McGill Nutrition and Performance Laboratory
McGill University Health Centre/Research Institute of the McGill University Health Centre