Clinical trial · Interventional
Prehabilitation on Fitness, Surgical Outcomes and Mitochondria Functionality in Patients With Esophageal Cancer
Efficacy of Prehabilitation on Fitness, Surgical Outcomes and Mitochondria Functionality in Patients With Esophageal Cancer Undergoing Neoadjuvant Chemotherapy
- 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)
The most often reported complications of patients with resectable esophageal malignancies are pulmonary (25\~57%), which may cause increased intensive care unit utilization, prolonged length of hospital stay, increased mortality and medical expense. Also, neoadjuvant chemotherapy has a deleterious effect on patients' cardiopulmonary capacity, strength and muscle mass. Prehabilitation includes preoperative exercise training and nutrition management. The reporting outcome regarding whether it improves surgical outcomes is inconsistent. One of the reasons is that pulmonary complication tends to occur in patients with low cardiopulmonary fitness, but all studies included patients with all level of fitness. Most of the chemotherapy interferes with cell division to inhibit tumor growth but is also harmful to mitochondria functionality. For example, Cisplatin and Paclitaxel, commonly used in esophageal cancer, alter mitochondria function, caused by disruption of respiratory chain function and increased production of reactive oxygen species. However, it remains unclear their negative effects on the oxidative phosphorylation capacity of mitochondria (OXPHOS). Furthermore, whether prehabilitation reverses this negative effect is scarcely explored. Patients will be inquired to participate and randomized into prehabilitation or control group. The latter will undergo conventional therapy only, while the former will receive additional prehabilitation program. The prehabilitation program encompasses supervised and home-based aerobic, resistance training (large and inspiratory muscle) and nutrition management. The supervised exercise training will be performed right before or after the radiotherapy. Outcome variables are fitness-related testing \[the 1st year\], quality of life and surgical outcomes \[the 2nd year\] and mitochondria functionality (OXPHOS, membrane potential, matrix oxidant burden) \[the 3rd year\]. Evaluation is performed 3 times at baseline, before surgery and 4 weeks after surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- prehabilitation (P)
- description
- inhospital exercise training 5 times/week, 5\~6 weeks during nCRT (neoadjuvant chemoraiotherapy); home exercise 5 times/week, 5\~6 weeks, between completion of nCRT and before surgery
- interventionNames
- Other: prehabilitation
- type
- NO_INTERVENTION
- label
- control group (C)
- description
- no prehabilitation
Primary outcomes (4)
- measure
- Exercise capacity of all participants by Cardiopulmonary Exercise Test (CPET)
- timeFrame
- three years
- description
- Cardiopulmonary Exercise Test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * nonmetastatic esophageal cancer patients. * V'O2 \< 21ml/min/kg * abnormality on spirometry. Exclusion Criteria: * Resting heart rate greater than 100 beats per minute * Atrial fibrillation or flutter * Poor control of high blood pressure or diabetes * Patients with peripheral arterial occlusive disease * Patients with end-stage renal disease * Patients receiving anticoagulant therapy * Neurological instability
References
Publications (0)
Data not yet available