Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial.
BACKGROUND
Weight loss in pancreatic cancer is associated with maldigestion due to pancreatic duct obstruction. Pancreatic exocrine replacement therapy (PERT) may significantly improve fat and protein absorption.


OBJECTIVE
This prospective, double-blind, randomized, placebo-controlled phase II trial assessed whether PERT could reduce or prevent weight loss in patients with unresectable pancreatic cancer.


METHODS
Sixty seven patients with unresectable pancreatic cancer were randomized to receive enteric coated PERT, consisting of 6-9 capsules of pancreatin (457.7 mg/capsule), or placebo. Patients took two capsules each three times daily during main meals and one capsule each up to three times daily when having between-meal snacks. The primary endpoint was the percentage change in body weight at eight weeks.


RESULTS
The mean percentage change in body weight (1.49% [1.12 kg] vs. 2.99% [1.63 kg], P = 0.381) and the mean percent change in Patient-Generated Subjective Global Assessment (PG-SGA) score (8.85% vs. 15.69%, p = 0.18) did not differ significantly between the PERT and placebo groups. There was no improvement in quality of life and overall survival did not differ significantly between the PERT and placebo groups (5.84 months vs 8.13 months, p = 0.744).


CONCLUSIONS
PERT did not reduce weight loss in patients with unresectable pancreatic cancer. Larger randomized trials are needed to identify those patients who may benefit from PERT.


BACKGROUND
ClinicalTrials.gov Number NCT01587534.
Center for Liver Cancer, National Cancer Center, Republic of Korea. Electronic address: wsm@ncc.re.kr.
Sang Myung
SM
Woo
Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, Republic of Korea.
Jungnam
J
Joo
Department of Clinical Nutrition, National Cancer Center, Republic of Korea.
So Young
SY
Kim
Center for Liver Cancer, National Cancer Center, Republic of Korea.
Sang-Jae
SJ
Park
Center for Liver Cancer, National Cancer Center, Republic of Korea.
Sung-Sik
SS
Han
Center for Liver Cancer, National Cancer Center, Republic of Korea.
Tae Hyun
TH
Kim
Center for Liver Cancer, National Cancer Center, Republic of Korea.
Young Hwan
YH
Koh
Rehabilitation Medicine, National Cancer Center, Republic of Korea.
Seung Hyun
SH
Chung
Molecular Imaging and Therapy Branch, Research Institute, National Cancer Center, Republic of Korea.
Yun-Hee
YH
Kim
Emergency Department, National Cancer Center, Republic of Korea.
Hae
H
Moon
Center for Liver Cancer, National Cancer Center, Republic of Korea.
Eun Kyung
EK
Hong
Center for Liver Cancer, National Cancer Center, Republic of Korea. Electronic address: lwj@ncc.re.kr.
Woo Jin
WJ
Lee
D000328:Adult; D000368:Aged; D001835:Body Weight / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D046790:Pancreas, Exocrine; D010190:Pancreatic Neoplasms / Q000628:therapy*; D010194:Pancreatin / Q000008:administration & dosage / Q000627:therapeutic use*; D020799:Pancrelipase / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D015431:Weight Loss
D020799:Pancrelipase; D010194:Pancreatin
Early palliative care; Pancreatic cancer; Pancreatic exocrine insufficiency; Pancreatic exocrine replacement therapy