PREHABILITATION During Neoadjuvant Therapy in Patients With Cancer of the Upper Digestive Tract and Rectum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Individual patient compliance
研究概览
简要总结
The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).
详细描述
With the aim of achieving downstaging, downsizing, and reducing the risk of recurrence, neoadjuvant chemotherapy, possibly chemoradiotherapy - i.e. neoadjuvant therapy is indicated in the preoperative period for patients with cancer of the upper digestive tract and rectal cancer.
Chemotherapy has a negative impact not only on the overall physical and mental condition of the patient but also on the quality of life and on the daily activities of the individual, especially in the period when the organism is facing an abnormal stress load in the sense of extensive surgical procedures.
Recently, attention and efforts to improve postoperative morbidity and mortality have increasingly focused on the preoperative period. The concept of prehabilitation, which is defined as an intervention improving functional capacity before an upcoming physiological stressor, appears as a way to contribute to this. This fact is evidenced by a number of published references.
The main aim of the study is to confirm or refute the feasibility of the prehabilitation program during neoadjuvant therapy in two diagnostic groups of patients:
-
- Patients with cancer of the upper digestive tract
-
- Patients with rectal cancer
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
盲法说明
No masking is used in this study.
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
- •radically operable locally advanced cancer of the esophagus, esophagogastric junction, stomach
- •radically operable locally advanced carcinoma of the rectum
- •the patient is able to handle the planned surgical resection procedure
- •planned preoperative neoadjuvant therapy
- •age > 18 years
- •the ability to complete a spiroergometric examination
- •the ability to carry out a prehabilitation program consent to participate in the study confirmed by signing the informed consent
排除标准
- •contraindications for spiroergometric examination
- •limitation on the part of the locomotor system to spiroergometric examination or daily exercise (e.g. amputation, severe gonarthrosis, coxarthrosis)
- •inoperability determined by the interdisciplinary team
- •inability to manage the planned operational performance
- •acute surgical performance
- •synchronous malignant disease
- •multivisceral resection
- •planned non-surgical therapeutic procedure
- •incomplete data
结局指标
主要结局
Individual patient compliance
时间窗: 3 months
Number of days when the patient wore the smart bracelet and performed or attempted to perform the exercise program out of the total number of days in the monitored period
Number of patients completing the program
时间窗: 3 months
The number of patients who complete the prehabilitation program by the time of surgery.
Number of enrolled patients
时间窗: 3 months
The number of patients who express an interest in being included in the study from all patients diagnosed and indicated for neoadjuvant therapy in the monitored period. the reasons for refusal to enroll in the study will be monitored.
次要结局
- Laboratory examinations - CRP values(3 months)
- Laboratory examinations - procalcitonin level(3 months)
- Exercise program - perceived exertion(3 months)
- Changes in the quality of life(3 months)
- Changes in spirometry examination results(3 months)
- Exercise program - pressing force on the dynamometer(3 months)
- Parameters monitored by the anesthesiologist - preoperative analgesia(3 months)
- Exercise program - InBody examination(3 months)
- Exercise program - Body Mass Index(3 months)
- Parameters monitored by the anesthesiologist - morbidity assessment(3 months)
- Parameters monitored by the oncologist(3 months)
- Exercise program - number of steps/day(3 months)
- Parameters monitored by the anesthesiologist - pain assessment(3 months)
- Laboratory examinations - complete blood count(3 months)
- Parameters monitored by the anesthesiologist - ASA value(3 months)
- Parameters monitored by the anesthesiologist - postoperative opioid analgesia(3 months)
- Laboratory examinations - nutritional parameters(3 months)
- Laboratory examinations - coagulation factors (aPTTp(3 months)
- Laboratory examinations - coagulation factors (fibrinogen)(3 months)