esophageal cancer
Conditions
Interventions
before surgery Provide nutritional guidance such as required energy and protein content. Prescribe aerobic exercise and resistance training. surgery esophagectomy, which is the standard treatment f
Sponsors
Kyoto University Hospital
Osaka Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically proven esophageal cancer such as squamous cell carcinoma and adenocarcinoma. 2. scheduled to undergo esophagectomy, which is the standard treatment for esophageal cancer 3. esophagectomy can be scheduled about 21 (15 to 30) days after starting intervention. 4. gastric tube reconstruction and placement of enteral feeding tube are scheduled 5. age 20 to 80 years old 6. Eastern cooperative oncology group performance status 0 or 1 7. ADL(FIM) score is 120 or more. 8.possible to confirm body weight before 6 month (patient declaration, etc.) 9. someone (family members or healthcare professionals, supporters, etc.) can observe the patient's condition throughout the study period. 10. no severe organ failure (bone marrow, heart, lungs, liver, kidneys, etc.) and clinical findings or tests at the start of the intervention meet the following criteria: Hemoglobin: 8.0 g / dL or more Total bilirubin: 2.0 mg / dL or less AST, ALT: 150 IU / L or less eGFR 45 mL / min / 1.73m2 or more Resting indoor air SpO2: 90% or more, or PaO2: 60 Torr or more Resting heart rate: <120 beats / minute CRP: <5.0 mg / dL 11. written informed consent was obtained from the patient
Exclusion criteria
Exclusion criteria: 1.patients who had past history of treatment for esophageal cancer 2.patients who were treated for other cancer within 1 year before registration. 3. Patients with active double cancer who are expected to require surgery, chemotherapy, or radiation therapy within 3 months of the date of consent. 4. Patients who are judged to be difficult to undergo intervention due to heart disease, osteoarthritis, neurological disease, etc. 5. Patients with psychosis or psychiatric symptoms who are judged to have difficulty in participating in this trial 6. Patients who have difficulty with adequate food, oral intake of oral preparations, and digestion and absorption (patients with chronic nausea, vomiting or gastrointestinal obstruction, etc.) 7. Patients who had myocardial infarction or unstable angina within 6 months of study enrollment 8. Patients with uncontrolled hypertension and persistent arrhythmias despite appropriate treatment (although patients with stable chronic atrial fibrillation receiving stable anticoagulant therapy are acceptable) (Patients who have pacemaker are excluded) 9. Diabetic patients who are or will be taking insulin. uncontrolled diabetics despite proper treatment. 10. Patients with heart failure, respiratory failure, liver failure 11. Patients who are judged to be inappropriate in intervention for reasons other than the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in skeletal muscle mass in thigh CT from registration to 4 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in skeletal muscle mass in Bioelectrical Impedance Analysis / abdominal CT from registration to 4 weeks after surgery 2. Change in skeletal muscle mass in Bioelectrical Impedance Analysis / abdominal and thigh CT from registration to before surgery and from registration to 12 weeks after surgery 3. postoperative complications 4. following items in time of registration, before surgery, 4weeks after, 12 weeks after, 24 weeks after and 48 weeks after surgery. physical function (body weight, grip strength, gait speed, stand and sit test, Knee extension muscle strength, and 6MWD. nutrition index(CONUT score, calorie intake) amount of exercise(IPAC, physical activity) questionnaire (FIM, QLQC30, Cancer fatigue scale) completion rate of intervention adverse events (joint pain, fracture, fall, bowel obstruction, diarrhea) 5. following items 4weeks, 12weeks, 24 weeks and 48weeks after surgery obstruction of feeding tube complication associated with feeding tube 6. vitamin D at registration, before surgery and 4 weeks after surgery. 7. tumor micro environment of resected specimen | — |
Countries
Japan
Contacts
Public ContactKohei Ueno
Kyoto University Department of surgery
Outcome results
None listed