Pancreatic cancer Pancreatic cancer
Conditions
Interventions
Patients will be randomized by day 6 after pancreaticoduodenectomy. From day 7, patients will start anamorelin hydrochloride 100 mg oral-intake once daily upon awakening. The duration of the intake w
Sponsors
Baba Taisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who underwent pancreatoduodenectomy for pancreatic cancer, have started oral intake by the 7th postoperative day, and have been judged by physician examination and x-ray photos to have an acceptable increase in food intake after starting anamorelin oral administration. 2) Patients who have understood and agreed the concept of the study. 3) Age more than 18, regardless of gender, preoperative complications, or stage of cancer.
Exclusion criteria
Exclusion criteria: 1) Patients who have been diagnosed with benign disease/precancerous lesions 2) Patients with benign/Premalignant lesions. 3) Patients allergic to anamorelin 4) Patients with contraindications to anamorelin (congestive heart failure, myocardial infarction/angina pectoris, severe stimulatory conduction system disorders, hepatic dysfunction (Child-Pugh class B and C), concomitant contraindication: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products 5) Patients who are not eligible for the study by the investigators decision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of postoperative weight loss compared to preoperative weight (the lowest weight by 13 weeks after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Compare the induction date of adjuvant chemotherapy (AC) and the intensity of AC (initial dose and frequency of discontinuation) 2) Compare the nutrition status using several blood-test-based indices (serum albumin, Lymphocyte count, PNI, mGPS, CONUT score). 3) Overall survival and recurrence free survival | — |
Contacts
Public ContactTaisuke Baba
Nagoya University Hospital
Outcome results
None listed