Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer (OESOFIT)
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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Martina Lojová, PhD
- Telefonnummer: +420543136232
- E-post: martina.lojova@mou.cz
Studera Kontakt Backup
- Namn: Tereza Štěpánková, PhD
- Telefonnummer: +420543136223
- E-post: tereza.stepankova@mou.cz
Studieorter
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Brno, Tjeckien, 65653
- Rekrytering
- Masaryk Memorial Cancer Institute
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Kontakt:
- Martina Lojová, PhD
- Telefonnummer: +420543136232
- E-post: martina.lojova@mou.cz
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Kontakt:
- Tereza Štěpánková, PhD
- Telefonnummer: +420543136223
- E-post: tereza.stepankova@mou.cz
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Huvudutredare:
- Radka Lordick Obermannová, Doc, MD, PhD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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
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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.
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Evaluation of the root mean square of successive differences in milliseconds between heartbeats to assess parasympathetic activity.
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Total score on the Pittsburgh Sleep Quality Index questionnaire (range 0-21), where higher scores indicate poorer sleep quality
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Health-Related Quality of Life as Measured by the EORTC QLQ-C30 Questionnaire
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Global health status/Quality of life scale score (range 0-100) from the European Organisation for Research and Treatment of Cancer core questionnaire
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Fatigue Severity as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue Scale
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Total score on the 13-item fatigue subscale (range 0-52), where lower scores indicate higher levels of fatigue.
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Cardiorespiratory Fitness as Measured by Peak Oxygen Consumption (VO2 peak)
Tidsram: Baseline (pre-intervention), 1 year
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Peak oxygen uptake measured in ml/kg/min during a cardiopulmonary exercise test on a cycle ergometer.
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Baseline (pre-intervention), 1 year
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Change From Baseline in Muscle Strength as Measured by Handgrip Dynamometry
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Maximum grip strength measured in kilograms (kg) using a calibrated handheld dynamometer.
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Baseline (pre-intervention), Perioperative, 1 year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Incidence of Postoperative Respiratory Complications
Tidsram: Perioperative
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Percentage of participants experiencing respiratory complications (e.g., pneumonia, respiratory failure) as defined by the Clavien-Dindo classification (Grade II or higher).
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Perioperative
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Incidence of Anastomotic Dehiscence
Tidsram: Perioperative
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Percentage of participants with radiologically or clinically confirmed leakage at the site of surgical anastomosis.
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Perioperative
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Change From Baseline in Daily Physical Activity Level as Measured by Average Daily Step Count
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Average number of steps per day recorded by a digital pedometer/accelerometer.
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Lean Body Mass as Measured by Bioelectrical Impedance Analysis
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Total lean body mass measured in kilograms (kg) using a multi-frequency Bioelectrical Impedance Analysis device.
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Nutritional Intake (Protein Intake)
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Daily protein intake measured in grams per kilogram of body weight (g/kg/day) based on a 3-day food record.
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Baseline (pre-intervention), Perioperative, 1 year
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Change From Baseline in Psychological Distress as Measured by the Hospital Anxiety and Depression Scale
Tidsram: Baseline (pre-intervention), Perioperative, 1 year
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Total score for anxiety and depression subscales (each range 0-21) to evaluate the impact of psychological support.
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Baseline (pre-intervention), Perioperative, 1 year
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Radka Lordick Obermannová, Doc, MD, PhD, Masaryk Memorial Cancer Institute
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 10.23736/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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Neoplasmer i magen
- Esofagusneoplasmer
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Undersökningstekniker
- Terapeutik
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Folkhälsa
- Miljö och folkhälsa
- Befolkningsegenskaper
- Näringsterapi
- Hälsostatus
- Demografi
- Epidemiologiska mätningar
- Perioperativ vård
- Hälsa
- Fysisk kondition
- Livskvalitet
- Förbättrad återhämtning efter operationen
- Kliniska laboratorietekniker
- Näringsstöd
- Kardiorespiratorisk kondition
Andra studie-ID-nummer
- A12/23
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- CSR
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