A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer
| Autor: | Kei Saito, Kazunaga Ishigaki, Dai Akiyama, Suguru Mizuno, Tsuyoshi Takeda, Yousuke Nakai, Rie Uchino, Hiroyuki Isayama, Kaoru Takagi, Naminatsu Takahara, Tsuyoshi Hamada, Gyotane Umefune, Kenji Hirano, Ryunosuke Hakuta, Kazuhiko Koike, Dai Mohri, Takeo Watanabe, Minoru Tada, Yukiko Ito, Tomotaka Saito, Hirofumi Kogure, Hiroshi Yagioka, Saburo Matsubara, Osamu Togawa, Natsuyo Yamamoto |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Oncology medicine.medical_specialty Endocrinology Diabetes and Metabolism Nutritional Status Kaplan-Meier Estimate Body Mass Index law.invention 03 medical and health sciences 0302 clinical medicine Endocrinology Gastrointestinal Agents Randomized controlled trial law Pancreatic cancer Internal medicine Antineoplastic Combined Chemotherapy Protocols Internal Medicine medicine Humans Enzyme Replacement Therapy Aged Aged 80 and over Unresectable Pancreatic Cancer Hepatology Pancrelipase business.industry Gastroenterology Nutritional status Middle Aged medicine.disease Pancreatic Neoplasms Treatment Outcome Multicenter study 030220 oncology & carcinogenesis Exocrine Pancreatic Insufficiency Female 030211 gastroenterology & hepatology Open label business Body mass index Pancreatic enzymes |
| Zdroj: | Pancreas. 47:800-806 |
| ISSN: | 1536-4828 0885-3177 |
| DOI: | 10.1097/mpa.0000000000001079 |
| Popis: | Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients.Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival.A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070).In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy. |
| Databáze: | OpenAIRE |
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