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Table 1 Inclusion and exclusion criteria

From: A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer: the NEXTAC-TWO study protocol

Inclusion Criteria
 1) Diagnosis of advanced non-small cell lung cancer or inoperable pancreatic cancer
 2) Scheduled for systemic cancer therapy (i.e. chemotherapy, and/or targeted therapy and/or immunotherapy)
  i. In pancreatic cancer patients, planned systemic chemotherapy only allows of the combination of gemcitabine with nanoparticle paclitaxel.
 3) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
 4) Age ≥ 70 years
 5) Body weight of 6 month ago can be confirmed
 6) An expected survival of ≥3 months as judged by investigators
 7) Written informed consent
 8) Adequate organ function
  i. Hemoglobin ≥8.0 g/dl
  ii. Total bilirubin ≤2.0 mg/dl
  iii. Aspartate aminotransferase ≤150 IU/L
  iv. Alanine aminotransferase ≤150 IU/L
  v. Serum creatinine ≤2.0 mg/dl
  vi. Arterial oxygen saturation (SpO2) ≥ 90% or partial pressure of oxygen in arterial blood (PaO2) ≥ 60 Torr in room air
  vii. Resting heart rate < 120 beat per minute
Exclusion criteria
 1) Patients received prior chemotherapy except adjuvant chemotherapy
 2) Active malignancy requiring cancer treatment including chemotherapy, radiotherapy and surgery within 3 months
 3) Patients who need nursing care at following situation (based on Katz Index)
  i. Bathing
  ii. Dressing
  iii. Transferring
  iv. Feeding
 4) Symptomatic brain metastasis or leptomeningeal carcinoma
 5) Bone metastasis with high risk of fracture
 6) Patients who are difficult to evaluate or intervene with cardiovascular disease, bone and joint disease, neuromuscular disease etc.
 7) Patients who are difficult to participant due to psychiatric disorder
 8) Patients who are difficult to oral intake
 9) History of acute myocardial infarction, unstable angina, uncontrollable hypertension, and symptomatic sustained arrhythmia within 6 months. Stable atrial fibrillation treated with appropriate anticoagulation therapy is allowed.
 10) Uncontrollable diabetes mellitus
 11) Patients whose appropriate period has not passed since prior treatment
  i. Surgery: 7 days
  ii. Palliative radiation: 1 day
  iii. Minor surgery (i.e. biopsy): 1 day
 12) Screening failure
  i. Patients who failed to wear the accelerometer for more than 4 days
  ii. Patients who could not properly handle the accelerometer
  iii. Patients who failed to initiate first-line therapy within 14 days of enrollment