Fit for Surgery. Clinical Randomized Trial of Multimodal Prehabilitation Strategy in Patients With Colorectal Cancer.
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Complications
研究概览
简要总结
Randomized clinical trial of multimodal prehabilitation in vulnerable patients with colon or rectal cancer prior to surgery.
详细描述
Fit for surgery is a randomized clinical trial of multimodal prehabilitation prior to colon or rectal cancer surgery. Participants will either receive
The study is a part of the PREHAB study which is performed in collaboration with international centers.
The full protocol are published BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions neither participant, care provider or investigator is blinded. Outcome assessor of primary outcomes are blinded.
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
- •Undergoing elective colorectal cancer surgery
- •WHO performance status I and II
- •Signed consent
排除标准
- •Known metastatic disease
- •Unable to perform baseline test or basic training e.g. paralytic or completely immobilized patients, orthopedic impairments.
- •ASA 4 or 5 (American Society of Anesthesiologist Classification)
- •Neoadjuvant chemo- or radiation therapy
- •Renal failure III B or higher
- •Illiteracy or unable to write or understand Danish
- •Cognitive disabilities, which affects adherence e.g. severe dementia (MMSE score ≤17).
- •Withdrawal of consent.
结局指标
主要结局
Complications
时间窗: 30 days after surgery
Complications measured by the comprehensive complication index. The score ranges from 0-100 with with a higher value indicating a worse outcome.
Changes in physical fitness prior to surgery
时间窗: Baseline, prior to surgery and 30 days after surgery
Changes in VO2 max between baseline and prior to surgery
Changes in immunological function
时间窗: Blood work taken at baseline, prior to surgery, three days after surgery and four weeks after surgery. Tumor from resectionspecimen
Changes in immunological function measured by nanostring in blood and tumor (in the invasive front)
Quality of Recovery 15
时间窗: 3 days after surgery
Difference in postoperative recovery between baseline and within 3 days after surgery. The cumulative score ranges from 0-150, with a higher value indicating a better outcome
次要结局
- Disease specfic quality of life - EORTC c29(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Overall quality of life - SF-36(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Psychological health - Depression - PHQ-9(the day prior to surgery,30 days after surgery, 60 days after surgery and one year after surgery)
- Disease specific quality of life - EORTC c30(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Physical function (Leg extension test)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Psychological health - General anxiety - GAD-7(the day prior to surgery, 30 days after surgery, 60 days after surgery and one year after surgery)
- Physical function (STS)(The day prior to surgery, 30 days after surgery, and 60 days after surgery.)
- Physical function (Stair climb test)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Physical function (6-MWT)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Physical function (Hand grip strength)(The day prior to surgery, 30 days after surgery, and 60 days after surgery)
- Remission and cancer free survival(5 years)
- Nutritional status(The day prior to surgery, 30 days after surgery, and 60 days after surgery)