Weight loss prevention after PD using Anamoreli
- Conditions
- C253Pancreatic cancer
- Registration Number
- JPRN-jRCTs041230138
- Lead Sponsor
- Baba Taisuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
1) Patients who underwent laparoscopic/robotic-assisted surgery, or 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of postoperative weight loss compared to preoperative weight (the lowest weight by 13 weeks after surgery)
- Secondary Outcome Measures
Name Time Method 1) Compare the induction date of adjuvant chemotherapy (AC) and the intensity of AC (initial dose and frequency of discontinuation)<br>2) Compare the nutrition status using several blood-test-based indices (serum albumin, Lymphocyte count, PNI, mGPS, CONUT score).<br>3) Overall survival and recurrence free survival