Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. juni 2026 opdateret af: Masaryk Memorial Cancer Institute

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tjekkiet
      • Brno, Tjekkiet, 65653
        • Rekruttering
        • Masaryk Memorial Cancer Institute
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Radka Lordick Obermannová, Doc, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interventional
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
Diagnostisk test: 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.
Andet: Exercises you can do on your own at home
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.
Andet: Enhanced Recovery After Surgery ERAS
  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.
Andet: Nutritional support
  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
Andet: Psychological support
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.
Andet: Quality of life
It is assessed using standardized questionnaires.
Diagnostisk test: Laboratory tests
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability
Tidsramme: Baseline (pre-intervention), Perioperative, 1 year
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
Tidsramme: 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
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Health-Related Quality of Life as Measured by the EORTC QLQ-C30 Questionnaire
Tidsramme: 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
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Fatigue Severity as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Tidsramme: 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.
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Cardiorespiratory Fitness as Measured by Peak Oxygen Consumption (VO2 peak)
Tidsramme: Baseline (pre-intervention), 1 year
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
Tidsramme: Baseline (pre-intervention), Perioperative, 1 year
Maximum grip strength measured in kilograms (kg) using a calibrated handheld dynamometer.
Baseline (pre-intervention), Perioperative, 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Postoperative Respiratory Complications
Tidsramme: Perioperative
Percentage of participants experiencing respiratory complications (e.g., pneumonia, respiratory failure) as defined by the Clavien-Dindo classification (Grade II or higher).
Perioperative
Incidence of Anastomotic Dehiscence
Tidsramme: Perioperative
Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.
Perioperative
Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count
Tidsramme: Baseline (pre-intervention), Perioperative, 1 year
Average number of steps per day recorded by a digital pedometer/accelerometer.
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis
Tidsramme: Baseline (pre-intervention), Perioperative, 1 year
Total lean body mass measured in kilograms (kg) using a multi-frequency Bioelectrical Impedance Analysis device.
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Nutritional Intake (Protein Intake)
Tidsramme: 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.
Baseline (pre-intervention), Perioperative, 1 year
Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale
Tidsramme: Baseline (pre-intervention), Perioperative, 1 year
Total score for anxiety and depression subscales (each range 0-21) to evaluate the impact of psychological support.
Baseline (pre-intervention), Perioperative, 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Masaryk Memorial Cancer Institute

Efterforskere

  • Ledende efterforsker: Radka Lordick Obermannová, Doc, MD, PhD, Masaryk Memorial Cancer Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2023

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A12/23

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD to be shared in pseudonymized form during the study. IPD to be published in anonymized form.

IPD-delingstidsramme

after study completion

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner