A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer

Tomotaka Saito; Yousuke Nakai; Hiroyuki Isayama; Kenji Hirano; Kazunaga Ishigaki; Ryunosuke Hakuta; Tsuyoshi Takeda; Kei Saito; Gyotane Umefune; Dai Akiyama; Takeo Watanabe; Kaoru Takagi; Naminatsu Takahara; Tsuyoshi Hamada; Rie Uchino; Suguru Mizuno; Dai Mouri; Hiroshi Yagioka; Hirofumi Kogure; Osamu Togawa; Saburo Matsubara; Yukiko Ito; Natsuyo Yamamoto; Minoru Tada; Kazuhiko Koike

doi:10.1097/MPA.0000000000001079

A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer

Tomotaka Saito, Yousuke Nakai, Hiroyuki Isayama, Kenji Hirano, Kazunaga Ishigaki, Ryunosuke Hakuta, Tsuyoshi Takeda, Kei Saito, Gyotane Umefune, Dai Akiyama, Takeo Watanabe, Kaoru Takagi, Naminatsu Takahara, Tsuyoshi Hamada, Rie Uchino, Suguru Mizuno, Dai Mouri, Hiroshi Yagioka, Hirofumi Kogure, Osamu TogawaSaburo Matsubara, Yukiko Ito, Natsuyo Yamamoto, Minoru Tada, Kazuhiko Koike

Research output: Contribution to journal › Article › peer-review

26 Citations (Scopus)

Abstract

Objective 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. Methods 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. Results 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). Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

Original language	English
Pages (from-to)	800-806
Number of pages	7
Journal	Pancreas
Volume	47
Issue number	7
DOIs	https://doi.org/10.1097/MPA.0000000000001079
Publication status	Published - 1 Aug 2018
Externally published	Yes

Keywords

chemotherapy
nutritional status
pancreatic cancer
pancreatic enzyme replacement therapy
pancreatic exocrine insufficiency
pancrelipase

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/MPA.0000000000001079

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Saito, T., Nakai, Y., Isayama, H., Hirano, K., Ishigaki, K., Hakuta, R., Takeda, T., Saito, K., Umefune, G., Akiyama, D., Watanabe, T., Takagi, K., Takahara, N., Hamada, T., Uchino, R., Mizuno, S., Mouri, D., Yagioka, H., Kogure, H., ... Koike, K. (2018). A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer. Pancreas, 47(7), 800-806. https://doi.org/10.1097/MPA.0000000000001079

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title = "A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer",

abstract = "Objective 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. Methods 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. Results 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). Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.",

keywords = "chemotherapy, nutritional status, pancreatic cancer, pancreatic enzyme replacement therapy, pancreatic exocrine insufficiency, pancrelipase",

author = "Tomotaka Saito and Yousuke Nakai and Hiroyuki Isayama and Kenji Hirano and Kazunaga Ishigaki and Ryunosuke Hakuta and Tsuyoshi Takeda and Kei Saito and Gyotane Umefune and Dai Akiyama and Takeo Watanabe and Kaoru Takagi and Naminatsu Takahara and Tsuyoshi Hamada and Rie Uchino and Suguru Mizuno and Dai Mouri and Hiroshi Yagioka and Hirofumi Kogure and Osamu Togawa and Saburo Matsubara and Yukiko Ito and Natsuyo Yamamoto and Minoru Tada and Kazuhiko Koike",

year = "2018",

month = aug,

day = "1",

doi = "10.1097/MPA.0000000000001079",

language = "English",

volume = "47",

pages = "800--806",

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Saito, T, Nakai, Y, Isayama, H, Hirano, K, Ishigaki, K, Hakuta, R, Takeda, T, Saito, K, Umefune, G, Akiyama, D, Watanabe, T, Takagi, K, Takahara, N, Hamada, T, Uchino, R, Mizuno, S, Mouri, D, Yagioka, H, Kogure, H, Togawa, O, Matsubara, S, Ito, Y, Yamamoto, N, Tada, M & Koike, K 2018, 'A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer', Pancreas, vol. 47, no. 7, pp. 800-806. https://doi.org/10.1097/MPA.0000000000001079

TY - JOUR

T1 - A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer

AU - Saito, Tomotaka

AU - Nakai, Yousuke

AU - Isayama, Hiroyuki

AU - Hirano, Kenji

AU - Ishigaki, Kazunaga

AU - Hakuta, Ryunosuke

AU - Takeda, Tsuyoshi

AU - Saito, Kei

AU - Umefune, Gyotane

AU - Akiyama, Dai

AU - Watanabe, Takeo

AU - Takagi, Kaoru

AU - Takahara, Naminatsu

AU - Hamada, Tsuyoshi

AU - Uchino, Rie

AU - Mizuno, Suguru

AU - Mouri, Dai

AU - Yagioka, Hiroshi

AU - Kogure, Hirofumi

AU - Togawa, Osamu

AU - Matsubara, Saburo

AU - Ito, Yukiko

AU - Yamamoto, Natsuyo

AU - Tada, Minoru

AU - Koike, Kazuhiko

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Objective 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. Methods 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. Results 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). Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

AB - Objective 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. Methods 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. Results 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). Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

KW - chemotherapy

KW - nutritional status

KW - pancreatic cancer

KW - pancreatic enzyme replacement therapy

KW - pancreatic exocrine insufficiency

KW - pancrelipase

UR - http://www.scopus.com/inward/record.url?scp=85050460181&partnerID=8YFLogxK

U2 - 10.1097/MPA.0000000000001079

DO - 10.1097/MPA.0000000000001079

M3 - Article

C2 - 29851751

AN - SCOPUS:85050460181

SN - 0885-3177

VL - 47

SP - 800

EP - 806

JO - Pancreas

JF - Pancreas

IS - 7

ER -

A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer

Abstract

Keywords

UN SDGs

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