Weight loss prevention after PD using Anamorelin

JRCT ID: jRCTs041230138

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 01/02/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 will be 12 weeks.

Outcome(s)

• Primary Outcome: Percentage of postoperative weight loss compared to preoperative weight (the lowest weight by 13 weeks after surgery)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Baba Taisuke