跳至主要内容
临床试验/NCT07671625
NCT07671625招募中不适用

A Comprehensive Preoperative and Postoperative Program Consisting Of Active Physical Therapy, A Comprehensive Nutritional Plan, And Psychological Support For Patients With Locally Advanced, Resectable Cancer Of The Esophagus, Gastroesophageal Junction, and Stomach

Masaryk Memorial Cancer Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability

研究概览

简要总结

Perioperative chemotherapy (CHT) or CHT/RT combined with surgery is the standard therapeutic approach for the treatment of locally advanced cancer of the esophagus, gastroesophageal junction (GEJ), and stomach. Comprehensive cancer treatment is associated with high perioperative morbidity and mortality. Serious postoperative complications occur in up to 20-80% of patients undergoing esophagectomy. The impact of nutritional status and overall physical condition on surgical outcomes and overall treatment has been demonstrated many times. The concept of pre-rehabilitation/pre-optimization, which involves establishing an individualized nutritional plan, monitoring and managing physical activity, and providing comprehensive supportive oncological and psychological care as early as during neoadjuvant CHT or CHT/RT, is a prerequisite for improving perioperative and 30-day postoperative morbidity and mortality.

详细描述

Standard care for locally advanced diseases includes perioperative chemotherapy or preoperative chemoradiotherapy, which can, in turn, lead to patient deconditioning prior to surgery. Efforts to overcome these complications led to the development of the ERAS (Enhanced Recovery After Surgery) program. This program overlaps with the emerging concept of prehabilitation/pre-optimization, which is based on identifying risk factors, formulating nutritional support, creating an exercise plan to improve overall physical fitness, and implementing continuous psychological support to enhance the patient's postoperative recovery.

The autonomic nervous system (ANS) is the body's primary homeostatic regulatory system, which can be negatively affected by anticancer treatment. Heart rate variability (HRV) is a suitable candidate for monitoring ANS function and can provide early indication of a deterioration in the sympathovagal balance of test subjects. As mentioned above, preoperative chemotherapy may further affect ANS function. It is known that regimens based on oxaliplatin and paclitaxel cause peripheral neuropathy and are associated with a significant impact on the adrenergic cardiovascular response and parasympathetic cardiac innervation. We hypothesize that a controlled increase in physical cardiorespiratory fitness during the preoperative period could improve HRV and aerobic performance, taking into account the patient's current condition. An integral part of a comprehensive program should also be perioperative individualized nutritional support aimed at maintaining body weight and muscle mass. The most common adverse effects of cancer treatment include cardiac toxicity, peripheral neuropathy, cachexia, loss of appetite, cognitive changes, fatigue, nausea, pain, and sleep disturbances, which have a significant impact on patients' quality of life. For this reason, special attention must also be paid to psychological support during active cancer treatment and in follow-up care. Psychological assessment should serve as a long-term tool for patients and families both during and after the active treatment course. Considering all the above aspects, a comprehensive assessment prior to treatment initiation and a specialized comprehensive program should be approached as a prehabilitation process. Furthermore, this concept, together with ERAS and six-month postoperative follow-up, constitutes optimal management of patients with esophageal cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Consent to participate in the study
  • Age ≥ 18 years
  • Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment
  • Resectable disease
  • ECOG performance status 0-2
  • Ability to participate in a fitness program
  • Willingness to follow a nutritional plan and recommendations

排除标准

  • Disseminated disease

结局指标

主要结局

Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability

时间窗: Baseline (pre-intervention), Perioperative, 1 year

Evaluation of the root mean square of successive differences in milliseconds between heartbeats to assess parasympathetic activity.

Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index

时间窗: Baseline (pre-intervention), Perioperative, 1 year

Total score on the Pittsburgh Sleep Quality Index questionnaire (range 0-21), where higher scores indicate poorer sleep quality

Change From Baseline in Health-Related Quality of Life as Measured by the EORTC QLQ-C30 Questionnaire

时间窗: Baseline (pre-intervention), Perioperative, 1 year

Global health status/Quality of life scale score (range 0-100) from the European Organisation for Research and Treatment of Cancer core questionnaire

Change From Baseline in Fatigue Severity as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale

时间窗: Baseline (pre-intervention), Perioperative, 1 year

Total score on the 13-item fatigue subscale (range 0-52), where lower scores indicate higher levels of fatigue.

Change From Baseline in Cardiorespiratory Fitness as Measured by Peak Oxygen Consumption (VO2 peak)

时间窗: Baseline (pre-intervention), 1 year

Peak oxygen uptake measured in ml/kg/min during a cardiopulmonary exercise test on a cycle ergometer.

Change From Baseline in Muscle Strength as Measured by Handgrip Dynamometry

时间窗: Baseline (pre-intervention), Perioperative, 1 year

Maximum grip strength measured in kilograms (kg) using a calibrated handheld dynamometer.

次要结局

  • Incidence of Postoperative Respiratory Complications(Perioperative)
  • Incidence of Anastomotic Dehiscence(Perioperative)
  • Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count(Baseline (pre-intervention), Perioperative, 1 year)
  • Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis(Baseline (pre-intervention), Perioperative, 1 year)
  • Change From Baseline in Nutritional Intake (Protein Intake)(Baseline (pre-intervention), Perioperative, 1 year)
  • Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale(Baseline (pre-intervention), Perioperative, 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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