Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07671625

Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Locally Advanced Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Disseminated disease

Treatment and study plan

Cardiorespiratory fitness (FsPS)

Diagnostic Test

A 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

Exercise 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
  • 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.
  • Application of ERAS principles in the immediate preoperative period.
  • Application of ERAS principles intraoperatively.
  • Application of ERAS principles for the postoperative period.
  • Implementation of early detection of complications and their immediate resolution.

Nutritional Support

Other
  • Assessment of nutrition using the SGA (Seven-Point Subjective Global Assessment)
  • Assessment of nutritional status (nutritional requirements) using laboratory values, anthropometry, and bioimpedance
  • Assessment of weight loss or gain using selected parameters
  • Assessment of intake of regular food, oral dietary supplements, dietary modifications, and artificial nutrition

Psychological Support

Other

Psychological 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

It is assessed using standardized questionnaires.

Laboratory tests

Diagnostic Test

Monitoring 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.

Primary outcomes

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

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: Baseline (pre-intervention), 1 year

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

  6. Change From Baseline in Muscle Strength as Measured by Handgrip Dynamometry

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

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

Secondary outcomes

  1. Incidence of Postoperative Respiratory Complications

    Time frame: Perioperative

    Percentage of participants experiencing respiratory complications (e.g., pneumonia, respiratory failure) as defined by the Clavien-Dindo classification (Grade II or higher).

  2. Incidence of Anastomotic Dehiscence

    Time frame: Perioperative

    Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.

  3. Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

    Average number of steps per day recorded by a digital pedometer/accelerometer.

  4. Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

    Total lean body mass measured in kilograms (kg) using a multi-frequency Bioelectrical Impedance Analysis device.

  5. Change From Baseline in Nutritional Intake (Protein Intake)

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

    Daily protein intake measured in grams per kilogram of body weight (g/kg/day) based on a 3-day food record.

  6. Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale

    Time frame: Baseline (pre-intervention), Perioperative, 1 year

    Total score for anxiety and depression subscales (each range 0-21) to evaluate the impact of psychological support.

Study contacts

Contact information is provided by the study sponsor or research team.

Martina Lojová, PhD

CONTACT

[email protected]

+420543136232

Tereza Štěpánková, PhD

CONTACT

[email protected]

+420543136223

Sponsors and collaborators

Lead sponsor

Masaryk Memorial Cancer Institute

Other

Registry information

Official study title

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

Acronym: OESOFIT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.