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

NCT07671625 | Recruiting DMC

• 1 other identifier: A12/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Esophageal Cancer; Gastroesophageal Junction Cancer; Gastric Cancer

Keywords

autonomic nervous system; physiotherapy; gastric cancer; nutritional intervention; psychologic support; esophageal cancer

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline (pre-intervention), Perioperative, 1 year

• 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

  Baseline (pre-intervention), Perioperative, 1 year

• 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

  Baseline (pre-intervention), Perioperative, 1 year

• 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.

  Baseline (pre-intervention), Perioperative, 1 year

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

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

  Baseline (pre-intervention), 1 year

• Change From Baseline in Muscle Strength as Measured by Handgrip Dynamometry

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

  Baseline (pre-intervention), Perioperative, 1 year

Secondary Outcomes (6)

• 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

Study Arms (1)

Interventional

EXPERIMENTAL

Participants undergo a multimodal prehabilitation and perioperative optimization program. Intervention includes supervised home-based exercise training prescribed according to the ACSM FITT principles for 8 weeks, incorporating inspiratory muscle training initiated at 60% of baseline maximal inspiratory pressure and progressively adjusted based on perceived exertion, together with aerobic exercise at 60-80% heart rate reserve. Training is delivered via telemedicine with regular remote supervision. Cardiorespiratory fitness is assessed at baseline, after completion of neoadjuvant therapy, and 6 months postoperatively. Participants will receive comprehensive nutritional assessment and individualized nutritional support, structured psychological counseling at predefined study time points, and perioperative care according to ERAS principles. Quality of life is evaluated using validated questionnaires. Cellular and humoral immunity and endocrine function are monitored longitudinally using

Diagnostic Test: Cardiorespiratory fitness (FsPS); Other: Exercises you can do on your own at home; Other: Enhanced Recovery After Surgery ERAS; Other: Nutritional support; Other: Psychological support; Other: Quality of life; Diagnostic Test: Laboratory tests

Interventions

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.

Interventional

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.

Interventional

Enhanced Recovery After Surgery ERAS OTHER

1. 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.

Interventional

Nutritional support OTHER

1. 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

Interventional

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.

Interventional

Quality of life OTHER

It is assessed using standardized questionnaires.

Interventional

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Disseminated disease

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

RECRUITING

Related Publications (4)

• https://doi.org/10.1007/PL00007853

  BACKGROUND

• Kawata S, Hiramatsu Y, Shirai Y, Watanabe K, Nagafusa T, Matsumoto T, Kikuchi H, Kamiya K, Takeuchi H. Multidisciplinary team management for prevention of pneumonia and long-term weight loss after esophagectomy: a single-center retrospective study. Esophagus. 2020 Jul;17(3):270-278. doi: 10.1007/s10388-020-00721-0. Epub 2020 Feb 6.

  PMID: 32026048 BACKGROUND

• 10.23736/S0393-3660.18.03986-4

  BACKGROUND

• Adams SC, Schondorf R, Benoit J, Kilgour RD. Impact of cancer and chemotherapy on autonomic nervous system function and cardiovascular reactivity in young adults with cancer: a case-controlled feasibility study. BMC Cancer. 2015 May 18;15:414. doi: 10.1186/s12885-015-1418-3.

  PMID: 25981952 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Cardiorespiratory Fitness; Enhanced Recovery After Surgery; Nutritional Support; Quality of Life; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Physical Fitness; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Perioperative Care; Surgical Procedures, Operative; Nutrition Therapy; Therapeutics; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Radka Lordick Obermannová, Doc, MD, PhD

  Masaryk Memorial Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Lojová, PhD

CONTACT

+420543136232; martina.lojova@mou.cz

Tereza Štěpánková, PhD

CONTACT

+420543136223; tereza.stepankova@mou.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRESCREENING STAGING VISIT 1 (0-6 weeks before neoadjuvant therapy ± 7 days) NEOADJUVANT THERAPY (8-10 weeks before surgery ± 7 days) RE-STAGING VISIT 2 (2-4 weeks before surgery ± 7 days) VISIT 2a (max. one week before surgery) SURGERY (+ ERAS) VISIT 3 (30 days after surgery +/- 7 days) VISIT 4 (6 months after surgery +/- 4 weeks)

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 26, 2026
• Study Start: May 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: after study completion
• Access Criteria: During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team. After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator. The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.

Locations

CZ (1)