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.
Consent to participate in the study
Age ≥ 18 years
Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment
Resectable disease
Disseminated disease
Single group
Cardiorespiratory fitness (FsPS)
Diagnostic testA single measurement before the start of preoperative treatment (baseline), after completion of chemotherapy 4-2 weeks before surgery, and 6 months after surgery.
Exercises you can do on your own at home
Other interventionExercise training is prescribed in accordance with the guidelines for prescribing physical activity (the FITT methodology published by the ACSM in 2018) for a period of 2 months. Training is set at 60% of the baseline maximum inspiratory pressure (MIP) and is increased by 5% if the participant reports a rate of perceived exertion (RPE) \< 7 (RPE scale 1-10). Exercises is conducted under supervision using telemedicine technologies. Weekly online check-ins via video call using the MOU MEDDI platform (first 4 weeks), then once every 14 days. Alternatively, weekly training sessions at the gym for the first 4 weeks (3 times a week at home, walking for at least 30 minutes per training session), followed by independent training at home. The intensity of aerobic training is prescribed based on a target heart rate of 60-80% of the heart rate reserve. An important part of the evaluation is also the patient's adherence to the exercise intervention and their level of physical activity.
Enhanced Recovery After Surgery ERAS
Other intervention1. Preoperative evaluation in the Anesthesiology and Resuscitation Department (ARD)/Intensive Care Unit (ICU) and preoperative intensive care, assessment of the patient's condition, development of an anesthetic plan, and consultation with the patient and their family members. 2. Application of ERAS principles in the immediate preoperative period. 3. Application of ERAS principles intraoperatively. 4. Application of ERAS principles for the postoperative period. 5. Implementation of early detection of complications and their immediate resolution.
Nutritional support
Other intervention1. Assessment of nutrition using the SGA (Seven-Point Subjective Global Assessment) 2. Assessment of nutritional status (nutritional requirements) using laboratory values, anthropometry, and bioimpedance 3. Assessment of weight loss or gain using selected parameters 4. Assessment of intake of regular food, oral dietary supplements, dietary modifications, and artificial nutrition
Psychological support
Other interventionPsychological intervention is provided to each patient at the following time points: 1) upon enrollment in the study, 2) before surgery, 3) 30 days after surgery, and 4) 6 months after surgery.
Quality of life
Other interventionIt is assessed using standardized questionnaires.
Laboratory tests
Diagnostic testMonitoring of cellular and humoral immunity/endocrine function will be performed by flow cytometry using two peripheral blood samples (1 tube containing 2.7 mL of EDTA-anticoagulated blood and 1 tube containing 5 mL of anticoagulant-free blood for serum separation) at 4 time points: 1) upon study enrollment, 2) before surgery, 3) 30 days after surgery, and 4) 6 months after surgery. Multicolor (6 to 8 colors) protocols for the proposed immune profile have already been established.
Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability
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
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
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
Total score on the 13-item fatigue subscale (range 0-52), where lower scores indicate higher levels of fatigue.
Incidence of Postoperative Respiratory Complications
Percentage of participants experiencing respiratory complications (e.g., pneumonia, respiratory failure) as defined by the Clavien-Dindo classification (Grade II or higher).
Incidence of Anastomotic Dehiscence
Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.
Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count
Average number of steps per day recorded by a digital pedometer/accelerometer.
Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis
Total lean body mass measured in kilograms (kg) using a multi-frequency Bioelectrical Impedance Analysis device.
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