Invasive ductal adenocarcinoma of pancreas
Conditions
Interventions
Home-based exercise therapy 1. Aerobic exercise Fast walking with modified Borg Scale 4 or higher for a total of at least 30 minutes per day, at least 4 times per week. 2. 3-minute muscle trainin
Sponsors
Tokai University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20 years of age or older 2. Histopathological or cytological diagnosis of pancreatic adenocarcinoma 3. Patients with an ECOG score of 0 or 1. 4. No evidence of distant metastasis on imaging tests 5. Patients who have been fully informed and have given their free and voluntary written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Patients in which consent for participation in the research cannot be obtained from the research subject himself/herself 2. Patients with a history of serious drug hypersensitivity or allergy 3. Patients with a history of malignant tumors (*Cases with a recurrence-free period of at least 5 years, and cases of endoscopically curatively resected intramucosal cancer, curatively resected cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin may be registered) 4. Patients with active infection 5. Patients with diarrhea (Grade 3 or higher) 6. Patients with a history of interstitial pneumonia or pulmonary fibrosis 7. Patients with hepatic or renal dysfunction that precludes chemotherapy 8. Patients with uncontrolled ascites or pleural effusion 9. Patients with uncontrolled diabetes mellitus 10. Patients with uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmia 11. Patients with inability to ambulate 12. Patients with severe malnutrition 13. Patients with a history of serious neurological or psychiatric diseases or complications 14. Pregnant women, lactating women, and patients with the possibility (intention) of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lymphocyte-monocyte ratio (LMR) before and after preoperative adjuvant chemotherapy with home-based exercise therapy: rate of increase in the high LMR group when the cutoff value for LMR is 3.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Evaluation of nutritional immunological parameters (Inflammation-based prognostic score: IBPS) (prealbumin level, albumin level, neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), prognostic nutrition index (PNI), controlling nutritional status (CONUT)) (2) Relative dose intensity of preoperative adjuvant chemotherapy 3) Incidence of postoperative complications (Dindo Classification Grade III or higher) 4) Completion rate of adjuvant chemotherapy 5) Recurrence-free survival, 2-year recurrence-free survival 6) Safety of protocol treatment (adverse events) 7) Changes in body composition (muscle mass, fat mass, body fat percentage, etc.) 8) Evaluation of tumor microenvironment in resected histopathology specimens (evaluation of CD3, CD4, and CD8 T lymphocyte infiltration at the tumor margins and interior, and tumor-associated macrophage infiltration) | — |
Countries
Japan
Contacts
Public ContactTaro Mashiko
Tokai University Department of Gastroenterological Surgery
Outcome results
None listed