Locally Advanced Esophageal CancerOESOFITNCT07671625
Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer
A study testing Cardiorespiratory fitness (FsPS), Exercises you can do on your own at home and Enhanced Recovery After Surgery ERAS in people with Locally Advanced Esophageal Cancer and Gastroesophageal Junction Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Esophageal Cancer, Gastroesophageal Junction Cancer, Gastric Cancer
- What is being tested?
- Cardiorespiratory fitness (FsPS), Exercises you can do on your own at home and Enhanced Recovery After Surgery ERAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 2 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Disseminated disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Martina Lojová, PhD, +420543136232, martina.lojova@mou.cz
Tereza Štěpánková, PhD, +420543136223, tereza.stepankova@mou.cz
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Cardiorespiratory fitness (FsPS), Exercises you can do on your own at home, Enhanced Recovery After Surgery ERAS, Nutritional support, Psychological support
- Keywords
- autonomic nervous system, physiotherapy, gastric cancer, nutritional intervention, psychologic support, esophageal cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 homeOther
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 ERASOther
- 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 supportOther
- 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 supportOther
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 lifeOther
It is assessed using standardized questionnaires.
Laboratory testsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention), Perioperative, 1 year
Secondary outcomes (6)
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).
Measured: Perioperative
Incidence of Anastomotic Dehiscence
Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention), Perioperative, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start2 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radka Lordick Obermannová, Doc, MD, PhD, Principal investigator, Masaryk Memorial Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671625
- Sponsor's protocol ID
- A12/23
- Acronym
- OESOFIT
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
Publications
https://doi.org/10.1007/PL00007853
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.
PubMed 3202604810.23736/S0393-3660.18.03986-4
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.
PubMed 25981952
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07671625
- Acronym / sponsor ID
- OESOFIT / A12/23
- Keywords
- autonomic nervous system, physiotherapy, gastric cancer, nutritional intervention, psychologic support, esophageal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | 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 testsParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Disseminated disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory fitness (FsPS)A single measurement before the start of preoperative treatment (baseline), after completion of chemotherapy 4-2 weeks before surgery, and 6 months after surgery. | Diagnostic test | Interventional |
| Exercises you can do on your own at homeExercise 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. | Other | Interventional |
| Enhanced Recovery After Surgery ERAS1. 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. | Other | Interventional |
| Nutritional support1. 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 | Other | Interventional |
| Psychological supportPsychological 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. | Other | Interventional |
| Quality of lifeIt is assessed using standardized questionnaires. | Other | Interventional |
| Laboratory testsMonitoring 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. | Diagnostic test | Interventional |
Primary outcome
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.
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
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
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.
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.
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.
6 secondary outcomes
Incidence of Postoperative Respiratory Complications
Time frame: Perioperative
Incidence of Anastomotic Dehiscence
Time frame: Perioperative
Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Nutritional Intake (Protein Intake)
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale
Time frame: Baseline (pre-intervention), Perioperative, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Backgroundhttps://doi.org/10.1007/PL00007853
- Background: PubMed 32026048Kawata 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.
- Background10.23736/S0393-3660.18.03986-4
- Background: PubMed 25981952Adams 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.
- Individual participant dataSharing planned: Yes. IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radka Lordick Obermannová, Doc, MD, PhD principal investigator
Masaryk Memorial Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory fitness (FsPS), Exercises you can do on your own at home and Enhanced Recovery After Surgery ERAS in people with Locally Advanced Esophageal Cancer and Gastroesophageal Junction Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martina Lojová, PhD (+420543136232, martina.lojova@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability (time frame: Baseline (pre-intervention), Perioperative, 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671625, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.