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

25 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Tcheca
      • Brno, Tcheca, 65653
        • Recrutamento
        • Masaryk Memorial Cancer Institute
        • Contato:
        • Contato:
        • Investigador principal:
          • Radka Lordick Obermannová, Doc, MD, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Teste de diagnostico: 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.
Outro: 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.
Outro: 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.
Outro: 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
Outro: 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.
Outro: Quality of life
It is assessed using standardized questionnaires.
Teste de diagnostico: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change From Baseline in Autonomic Nervous System Balance as Measured by Heart Rate Variability
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: Baseline (pre-intervention), Perioperative, 1 year
Maximum grip strength measured in kilograms (kg) using a calibrated handheld dynamometer.
Baseline (pre-intervention), Perioperative, 1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of Postoperative Respiratory Complications
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Masaryk Memorial Cancer Institute

Investigadores

  • Investigador principal: Radka Lordick Obermannová, Doc, MD, PhD, Masaryk Memorial Cancer Institute

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de maio de 2023

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2026

Primeira postagem (Real)

26 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A12/23

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

after study completion

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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