A Phase II Single-Arm Study to Evaluate the Feasibility of Preoperative Rehabilitation and Nutrition Intervention in Patients Undergoing Neoadjuvant Chemotherapy for Esophageal Cancer
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000045479
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participation rate in preoperative intervention programs
- Secondary Outcome Measures
Name Time Method 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