Thoracic esophageal cancer
Conditions
Interventions
Outpatient rehabilitation guidance available (3 months)
No outpatient rehabilitation guidance
Sponsors
Japanese Association of Supportive Care in Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written consent is obtained from the patient. 2) The patient is scheduled to undergo radical open thoracotomy for thoracic esophageal cancer. 3) Patients must be at least 20 years old and less than 80 years old. 4) PS of 0 or 1. 5) Organ function is preserved. 6) Able to make outpatient visits after surgery. 7)Blood samples and assay results must meet all of the following conditions (laboratory tests must be performed within 14 days prior to the date of case enrollment)
Exclusion criteria
Exclusion criteria: 1) Patient has an infectious disease requiring systemic treatment. 2) Has a fever of 38 degrees or higher. 3) Pregnant, possibly pregnant, or lactating female patients. 4) Patients with psychosis or concomitant psychiatric symptoms that would preclude participation in the study. 5) Receiving continuous systemic administration (oral or intravenous) of steroids. 6) Patient has uncontrolled diabetes mellitus (HbA1c > 8%). 7) Patient has uncontrolled hypertension. 8) Complicated with unstable angina pectoris (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within 6 months. 9) Complicated interstitial pneumonia, pulmonary fibrosis, severe emphysema, or acute heart failure. 10) Has a history of cerebrovascular disease (e.g., cerebral infarction, intracerebral hemorrhage, transient ischemic attack) occurring within 6 months. 11) Has an active overlapping cancer. 12) Other patients deemed by the treating physician to be unsuitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shuttle Walking Test (SWT) distance at 3 months from discharge (T4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Participation rate of outpatient rehabilitation intervention, diary entries and collection rate for Group A 2) Percentage of Group A reaching intervention goals (percentage of weeks in which prescribed strength training was performed at least 2 days per week, percentage of weeks in which target number of steps was achieved at least 5 days per week) 3) Incidence of serious adverse events in group A 4) The following items in groups A and B at 3 months (T4), 6 months (T5), and 12 months (T6) after discharge Motor function (SWT distance, grip strength, 5 times chair stand test, physical activity) Skeletal muscle mass (measured by CT), diagnostic criteria for sarcopenia Nutritional status (body weight, CONUT (total lymphocyte count, Alb, TC)) Functional assessment of the elderly (G8) Quality of life (EORTC-QLQ-C30) Utilization of medical resources (cumulative length of hospital stay) Serious adverse events | — |
Countries
Japan
Contacts
Public ContactYUTAKA MIYAWAKI
Saitama Medical University International Medical Center Gastroenterological Surgery
Outcome results
None listed