An interventional study of Cardiorespiratory fitness (FsPS) and Exercises you can do on your own at home in Locally Advanced Esophageal Cancer, Gastroesophageal Junction Cancer and Gastric Cancer, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Supportive care
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.
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Masaryk Memorial Cancer Institute is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
A single measurement before the start of preoperative treatment (baseline), after completion of chemotherapy 4-2 weeks before surgery, and 6 months after surgery.
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.
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.
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
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.
It is assessed using standardized questionnaires.
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.
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-intervention), Perioperative, 1 year
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).
Time frame: Perioperative
Incidence of Anastomotic Dehiscence
Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.
Time frame: Perioperative
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.
Time frame: Baseline (pre-intervention), Perioperative, 1 year
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.
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Nutritional Intake (Protein Intake)
Daily protein intake measured in grams per kilogram of body weight (g/kg/day) based on a 3-day food record.
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale
Total score for anxiety and depression subscales (each range 0-21) to evaluate the impact of psychological support.
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Plan to share: Yes — IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Supporting information: Clinical study report
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.
Data sharing details ↗ · www.mou.cz
Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 43 months is above that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
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Masaryk Memorial Cancer Institute