esophageal cancer
Conditions
Interventions
Nutritional and rehabilitative interventions
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or basal cell carcinoma on endoscopic biopsy of the primary esophageal lesion. 2. The main locus of the lesion (primary tumor, intraesophageal metastasis, or intraepithelial extension) is located within the thoracic esophageal cancer or at the esophagogastric junction. 3. Patients scheduled to receive preoperative chemotherapy for esophageal cancer. 4.Patients must be at least 20 years old on the date of enrollment. 5. Performance status (PS) of 0 or 1 according to ECOG criteria. 6.Patients must be eligible for open thoracotomy (or thoracoscopy or robot-assisted surgery) and open abdominal surgery (or laparoscopy or robot-assisted surgery) for radical esophageal cancer (R0). 7.The patient's written consent to participate in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1. Infectious disease requiring systemic treatment. (Because rehabilitation is difficult) 2. Patient has a fever of 38 degrees Celsius or higher. (Due to difficulty in rehabilitation) Patient has poorly controlled diabetes mellitus (HbA1c of 6.5% or higher is the standard). (Due to difficulty in nutritional intervention) 4. Complicated psychosis or psychiatric symptoms, which will make it difficult to participate in the study. (Due to difficulty in rehabilitation) 5. Patient has poorly controlled hypertension. (Due to difficulty in rehabilitation) 6. Patient has unstable angina (angina pectoris with onset or worsening within the last 3 weeks) or myocardial infarction within the last 6 months. (Due to difficulty in rehabilitation) 7. Patient has interstitial pneumonia, pulmonary fibrosis, severe emphysema, or heart failure. (Due to difficulty in rehabilitation) 8. Patient has a history of cerebrovascular disease (cerebral infarction, intracerebral hemorrhage, transient ischemic attack, etc.) that occurred within 6 months. (Due to difficulty in rehabilitation) 9. Other patients who are deemed unsuitable for enrollment in this clinical trial by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation rate in preoperative intervention programs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Rate of exercise therapy and dietary guidance 2.Perioperative complication rate 3.Perioperative respiratory complication rate 4.Postoperative hospital stay 5.Sarcopenia assessment 1)Grip strength 2)Short Physical Performance Battery (SPPB) 3)SWT(Shuttle Walking Test) 4)Muscle mass 6.Frailty assessment 7.Activity level 8.Functional screening assessment for the elderly 9.Oral hygiene/feeding status/swallowing function assessment 10.Speech function assessment 11.Nutrition assessment 12.QOL assessment | — |
Countries
Japan
Contacts
Public ContactTakayuki Tsuji
Keio University Hospital General and Digestive Surgery
Outcome results
None listed