Clinical trial · Interventional
Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
| Locally Advanced Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiorespiratory fitness (FsPS) | Diagnostic Test | — | UNRESOLVED |
| Enhanced Recovery After Surgery ERAS | Other | — | UNRESOLVED |
| Exercises you can do on your own at home | Other | — | UNRESOLVED |
| Laboratory tests | Diagnostic Test | — | UNRESOLVED |
| Nutritional support | Other | — | UNRESOLVED |
| Psychological support | Other | — | UNRESOLVED |
| Quality of life | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- 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
- interventionNames
- 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
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDhttps://doi.org/10.1007/PL00007853
- BACKGROUNDKawata 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. PMID 32026048
- BACKGROUND10.23736/S0393-3660.18.03986-4
- BACKGROUNDAdams 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. PMID 25981952