Esophageal cancer
Conditions
Interventions
The intervention domains of prehabilitation during neoadjuvant chemotherapy consist of exercise and nutritional interventions, delivered through alternating inpatient (education phase) and outpatient
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients pathologically diagnosed with thoracic esophageal cancer (squamous cell carcinoma). Patients scheduled to undergo curative resection following neoadjuvant therapy with the DCF regimen. Patients aged 65 or more years at the time of enrollment. Patients with an ECOG Performance Status of 0 to 2. Patients capable of oral intake at the time of enrollment (Dysphagia score 2 or lower). Patients able to provide written informed consent. Patients able to understand the procedures for using an activity monitor and rehabilitation notebook. Patients prior to the initiation of neoadjuvant therapy.
Exclusion criteria
Exclusion criteria: Presence of systemic infection requiring treatment. Presence of fever 38 or more degrees Celsius. Presence of psychiatric disorders or psychiatric symptoms that are judged to make participation in the trial difficult. Receiving continuous systemic administration of corticosteroids (oral or intravenous). Presence of uncontrolled hypertension. Presence of unstable angina (new onset or worsening angina within the past 3 weeks) or history of myocardial infarction within the past 6 months. Presence of severe interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, or acute heart failure. History of cerebrovascular disease (such as cerebral infarction, intracerebral hemorrhage, or transient ischemic attack) within the past 6 months. Presence of active double cancer (*1). Any other condition judged by the principal investigator to make the patient unsuitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to the intervention program: adherence rate to the exercise and nutrition program (from the initiation of neoadjuvant chemotherapy to the completion of the final cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the intervention program (proportion of Grade 2 or more adverse events attributable to the exercise and nutrition program, assessed from initiation to completion of neoadjuvant chemotherapy cycles); skeletal muscle mass (Skeletal Muscle Mass Index [SMI] calculated from L3 CT images); physical activity (Global Physical Activity Questionnaire [GPAQ]); oral intake (Brief-type self-administered Diet History Questionnaire [BDHQ]); physical fitness (Incremental Shuttle Walk Test [ISWT]); nutritional status (body weight); functional status (WHO Disability Assessment Schedule ver. 2.0); and postoperative complications within 30 days (Clavien-Dindo classification grade II or higher). | — |
Countries
Japan
Contacts
Public ContactTsuyoshi HARADA
National Cancer Center Hospital East Department of Rehabilitation Medicine
Outcome results
None listed