A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer

The NEXTAC-TWO study protocol

Satoru Miura, Tateaki Naito, Shuichi Mitsunaga, Katsuhiro Omae, Keita Mori, Toshimi Inano, Teiko Yamaguchi, Noriatsu Tatematsu, Taro Okayama, Ayumu Morikawa, Takako Mouri, Hisashi Tanaka, Madoka Kimura, Hisao Imai, Takuro Mizukami, Akira Imoto, Chihiro Kondoh, Shinsuke Shiotsu, Hiroyuki Okuyama, Makoto Ueno & 6 others Toshiaki Takahashi, Tetsuya Tsuji, Hideki Aragane, Akio Inui, Takashi Higashiguchi, Koichi Takayama

Research output: Contribution to journalArticle

Abstract

Background: Most advanced elderly cancer patients experience fatigue, anorexia, and declining physical function due to cancer cachexia, for which effective interventions have not been established. We performed a phase I study of a new nonpharmacological multimodal intervention called the nutritional and exercise treatment for advanced cancer (NEXTAC) program and reported the excellent feasibility of and compliance with this program in elderly patients with advanced cancer who were at risk for cancer cachexia. We report here the background, hypothesis, and design of the next-step multicenter, randomized phase II study to evaluate the efficacy of the program, the NEXTAC-TWO study. Methods: Patients with chemo-naïve advanced non-small cell lung cancer or pancreatic cancer, age ≥ 70 years, performance status ≤2, with adequate organ function and without disability according to the modified Katz index will be eligible. In total, 130 participants will be recruited from 15 Japanese institutions and will be randomized into either the intervention group or a control group. Computer-generated random numbers are allocated to each participant. Stratification factors include performance status (0 to 1 vs. 2), site of primary cancer (lung vs. pancreas), stage (III vs. IV), and type of chemotherapy (cytotoxic vs. others). Interventions and assessment will be performed 4 times every 4 ± 2 weeks from the date of randomization. Interventions will consist of nutritional counseling, nutritional supplements (rich in branched-chain amino acids), and a home-based exercise program. The exercise program will include low-intensity daily muscle training and lifestyle education to promote physical activity. The primary endpoint is disability-free survival. It is defined as the period from the date of randomization to the date of developing disability or death due to any cause. This trial also plans to evaluate the improvements in nutritional status, physical condition, quality of life, activities of daily living, overall survival, and safety as secondary endpoints. Enrollment began in August 2017. The study results will demonstrate the efficacy of multimodal interventions for elderly cancer patients and their application for the maintenance of physical and nutritional conditions in patients with cancer cachexia. This work is supported by a grant-in-aid from the Japan Agency for Medical Research and Development. Discussion: This is the first randomized trial to evaluate the efficacy and safety of a multimodal intervention specific for elderly patients with advanced cancer.

Original languageEnglish
Article number528
JournalBMC Cancer
Volume19
Issue number1
DOIs
Publication statusPublished - 31-05-2019

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Pancreatic Neoplasms
Non-Small Cell Lung Carcinoma
Exercise
Neoplasms
Cachexia
Therapeutics
Random Allocation
Safety
Branched Chain Amino Acids
Survival
Organized Financing
Anorexia
Activities of Daily Living
Nutritional Status
Fatigue
Biomedical Research
Life Style
Counseling
Pancreas
Lung Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Miura, Satoru ; Naito, Tateaki ; Mitsunaga, Shuichi ; Omae, Katsuhiro ; Mori, Keita ; Inano, Toshimi ; Yamaguchi, Teiko ; Tatematsu, Noriatsu ; Okayama, Taro ; Morikawa, Ayumu ; Mouri, Takako ; Tanaka, Hisashi ; Kimura, Madoka ; Imai, Hisao ; Mizukami, Takuro ; Imoto, Akira ; Kondoh, Chihiro ; Shiotsu, Shinsuke ; Okuyama, Hiroyuki ; Ueno, Makoto ; Takahashi, Toshiaki ; Tsuji, Tetsuya ; Aragane, Hideki ; Inui, Akio ; Higashiguchi, Takashi ; Takayama, Koichi. / A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer : The NEXTAC-TWO study protocol. In: BMC Cancer. 2019 ; Vol. 19, No. 1.
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author = "Satoru Miura and Tateaki Naito and Shuichi Mitsunaga and Katsuhiro Omae and Keita Mori and Toshimi Inano and Teiko Yamaguchi and Noriatsu Tatematsu and Taro Okayama and Ayumu Morikawa and Takako Mouri and Hisashi Tanaka and Madoka Kimura and Hisao Imai and Takuro Mizukami and Akira Imoto and Chihiro Kondoh and Shinsuke Shiotsu and Hiroyuki Okuyama and Makoto Ueno and Toshiaki Takahashi and Tetsuya Tsuji and Hideki Aragane and Akio Inui and Takashi Higashiguchi and Koichi Takayama",
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Miura, S, Naito, T, Mitsunaga, S, Omae, K, Mori, K, Inano, T, Yamaguchi, T, Tatematsu, N, Okayama, T, Morikawa, A, Mouri, T, Tanaka, H, Kimura, M, Imai, H, Mizukami, T, Imoto, A, Kondoh, C, Shiotsu, S, Okuyama, H, Ueno, M, Takahashi, T, Tsuji, T, Aragane, H, Inui, A, Higashiguchi, T & Takayama, K 2019, 'A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer: The NEXTAC-TWO study protocol', BMC Cancer, vol. 19, no. 1, 528. https://doi.org/10.1186/s12885-019-5762-6

A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer : The NEXTAC-TWO study protocol. / Miura, Satoru; Naito, Tateaki; Mitsunaga, Shuichi; Omae, Katsuhiro; Mori, Keita; Inano, Toshimi; Yamaguchi, Teiko; Tatematsu, Noriatsu; Okayama, Taro; Morikawa, Ayumu; Mouri, Takako; Tanaka, Hisashi; Kimura, Madoka; Imai, Hisao; Mizukami, Takuro; Imoto, Akira; Kondoh, Chihiro; Shiotsu, Shinsuke; Okuyama, Hiroyuki; Ueno, Makoto; Takahashi, Toshiaki; Tsuji, Tetsuya; Aragane, Hideki; Inui, Akio; Higashiguchi, Takashi; Takayama, Koichi.

In: BMC Cancer, Vol. 19, No. 1, 528, 31.05.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer

T2 - The NEXTAC-TWO study protocol

AU - Miura, Satoru

AU - Naito, Tateaki

AU - Mitsunaga, Shuichi

AU - Omae, Katsuhiro

AU - Mori, Keita

AU - Inano, Toshimi

AU - Yamaguchi, Teiko

AU - Tatematsu, Noriatsu

AU - Okayama, Taro

AU - Morikawa, Ayumu

AU - Mouri, Takako

AU - Tanaka, Hisashi

AU - Kimura, Madoka

AU - Imai, Hisao

AU - Mizukami, Takuro

AU - Imoto, Akira

AU - Kondoh, Chihiro

AU - Shiotsu, Shinsuke

AU - Okuyama, Hiroyuki

AU - Ueno, Makoto

AU - Takahashi, Toshiaki

AU - Tsuji, Tetsuya

AU - Aragane, Hideki

AU - Inui, Akio

AU - Higashiguchi, Takashi

AU - Takayama, Koichi

PY - 2019/5/31

Y1 - 2019/5/31

N2 - Background: Most advanced elderly cancer patients experience fatigue, anorexia, and declining physical function due to cancer cachexia, for which effective interventions have not been established. We performed a phase I study of a new nonpharmacological multimodal intervention called the nutritional and exercise treatment for advanced cancer (NEXTAC) program and reported the excellent feasibility of and compliance with this program in elderly patients with advanced cancer who were at risk for cancer cachexia. We report here the background, hypothesis, and design of the next-step multicenter, randomized phase II study to evaluate the efficacy of the program, the NEXTAC-TWO study. Methods: Patients with chemo-naïve advanced non-small cell lung cancer or pancreatic cancer, age ≥ 70 years, performance status ≤2, with adequate organ function and without disability according to the modified Katz index will be eligible. In total, 130 participants will be recruited from 15 Japanese institutions and will be randomized into either the intervention group or a control group. Computer-generated random numbers are allocated to each participant. Stratification factors include performance status (0 to 1 vs. 2), site of primary cancer (lung vs. pancreas), stage (III vs. IV), and type of chemotherapy (cytotoxic vs. others). Interventions and assessment will be performed 4 times every 4 ± 2 weeks from the date of randomization. Interventions will consist of nutritional counseling, nutritional supplements (rich in branched-chain amino acids), and a home-based exercise program. The exercise program will include low-intensity daily muscle training and lifestyle education to promote physical activity. The primary endpoint is disability-free survival. It is defined as the period from the date of randomization to the date of developing disability or death due to any cause. This trial also plans to evaluate the improvements in nutritional status, physical condition, quality of life, activities of daily living, overall survival, and safety as secondary endpoints. Enrollment began in August 2017. The study results will demonstrate the efficacy of multimodal interventions for elderly cancer patients and their application for the maintenance of physical and nutritional conditions in patients with cancer cachexia. This work is supported by a grant-in-aid from the Japan Agency for Medical Research and Development. Discussion: This is the first randomized trial to evaluate the efficacy and safety of a multimodal intervention specific for elderly patients with advanced cancer.

AB - Background: Most advanced elderly cancer patients experience fatigue, anorexia, and declining physical function due to cancer cachexia, for which effective interventions have not been established. We performed a phase I study of a new nonpharmacological multimodal intervention called the nutritional and exercise treatment for advanced cancer (NEXTAC) program and reported the excellent feasibility of and compliance with this program in elderly patients with advanced cancer who were at risk for cancer cachexia. We report here the background, hypothesis, and design of the next-step multicenter, randomized phase II study to evaluate the efficacy of the program, the NEXTAC-TWO study. Methods: Patients with chemo-naïve advanced non-small cell lung cancer or pancreatic cancer, age ≥ 70 years, performance status ≤2, with adequate organ function and without disability according to the modified Katz index will be eligible. In total, 130 participants will be recruited from 15 Japanese institutions and will be randomized into either the intervention group or a control group. Computer-generated random numbers are allocated to each participant. Stratification factors include performance status (0 to 1 vs. 2), site of primary cancer (lung vs. pancreas), stage (III vs. IV), and type of chemotherapy (cytotoxic vs. others). Interventions and assessment will be performed 4 times every 4 ± 2 weeks from the date of randomization. Interventions will consist of nutritional counseling, nutritional supplements (rich in branched-chain amino acids), and a home-based exercise program. The exercise program will include low-intensity daily muscle training and lifestyle education to promote physical activity. The primary endpoint is disability-free survival. It is defined as the period from the date of randomization to the date of developing disability or death due to any cause. This trial also plans to evaluate the improvements in nutritional status, physical condition, quality of life, activities of daily living, overall survival, and safety as secondary endpoints. Enrollment began in August 2017. The study results will demonstrate the efficacy of multimodal interventions for elderly cancer patients and their application for the maintenance of physical and nutritional conditions in patients with cancer cachexia. This work is supported by a grant-in-aid from the Japan Agency for Medical Research and Development. Discussion: This is the first randomized trial to evaluate the efficacy and safety of a multimodal intervention specific for elderly patients with advanced cancer.

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DO - 10.1186/s12885-019-5762-6

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JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

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