A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO)
ABSTRACT Background In our previous study (NEXTAC‐ONE), the Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) program (including home‐based exercise and branched‐chain amino acid‐containing supplements combined with nutritional counselling) was shown to potentially prevent low muscle mas...
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2025-06-01
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| Series: | Journal of Cachexia, Sarcopenia and Muscle |
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| Online Access: | https://doi.org/10.1002/jcsm.13871 |
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| author | Shuichi Mitsunaga Tateaki Naito Hisao Imai Madoka Kimura Satoru Miura Hisashi Tanaka Takuro Mizukami Akira Imoto Chihiro Kondoh Hiroyuki Okuyama Makoto Ueno Shinsuke Shiotsu Toshimi Inano Haruka Chitose Noriatsu Tatematsu Taro Okayama Takako Mouri Miwa Sugiyama Katsuhiro Omae Takanori Kawabata Keita Mori Koichi Takayama |
| author_facet | Shuichi Mitsunaga Tateaki Naito Hisao Imai Madoka Kimura Satoru Miura Hisashi Tanaka Takuro Mizukami Akira Imoto Chihiro Kondoh Hiroyuki Okuyama Makoto Ueno Shinsuke Shiotsu Toshimi Inano Haruka Chitose Noriatsu Tatematsu Taro Okayama Takako Mouri Miwa Sugiyama Katsuhiro Omae Takanori Kawabata Keita Mori Koichi Takayama |
| author_sort | Shuichi Mitsunaga |
| collection | DOAJ |
| description | ABSTRACT Background In our previous study (NEXTAC‐ONE), the Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) program (including home‐based exercise and branched‐chain amino acid‐containing supplements combined with nutritional counselling) was shown to potentially prevent low muscle mass‐related disability in elderly cancer patients. This randomized controlled trial (NEXTAC‐TWO) was conducted to elucidate whether the NEXTAC program prolongs disability‐free survival in elderly patients with advanced pancreatic or non‐small cell lung cancer. Methods This open‐label, multicentre, randomized phase II study was conducted at 15 Japanese hospitals. Patients aged ≥ 70 years, with pathologically proven advanced pancreatic or non‐small cell lung cancer, who were scheduled to undergo systemic chemotherapy for treatment‐naïve tumours were randomly assigned (1:1) to undergo observation or receive the NEXTAC program for 12 weeks. Randomization was performed by the minimization method, using performance status and types with cancer diagnosis and anticancer treatment as adjustment factors. The primary endpoint was disability‐free survival (period from randomization to the date patients were evaluated as needing care or death due to any cause). Key secondary endpoints were change in weight, muscle mass, physical activity, nutritional assessment, safety and survival. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000028801). Results From 2017 to 2019, 131 patients were enrolled and randomly assigned to NEXTAC (n = 66) or control arms (n = 65, median age 76.0 years). After randomization, two patients in the NEXTAC arm declined further participation. As a result, 64 patients (median age 75.5 years) received at least one session of the NEXTAC program. The completion rate of the planned exercise and nutrition consultation sessions was 98.4% in the NEXTAC arm. Of the 129 patients, 91 (71%) had a disability (44 in the NEXTAC arm; 47 in the control arm). In the primary analysis, median disability‐free survival periods were 478 days (95% confidence interval [CI], 358–576) in the NEXTAC arm and 499 days in the control arm (95% CI, 363–604), with no significant differences between them (p = 0.884). The hazard ratio for disability‐free survival in the NEXTAC arm compared with the control arm was 0.970 (95% CI 0.642–1.465). There were no differences in the secondary endpoints between the two arms. Conclusions The patients had good compliance with the 12‐week NEXTAC program but failed to show significant improvements in disability‐free survival as compared to observation alone. Further study on the progression of low muscle mass in the NEXTAC arm is needed. |
| format | Article |
| id | doaj-art-ceee0357e0794be08e807f35fa13d100 |
| institution | Kabale University |
| issn | 2190-5991 2190-6009 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Cachexia, Sarcopenia and Muscle |
| spelling | doaj-art-ceee0357e0794be08e807f35fa13d1002025-08-20T03:26:37ZengWileyJournal of Cachexia, Sarcopenia and Muscle2190-59912190-60092025-06-01163n/an/a10.1002/jcsm.13871A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO)Shuichi Mitsunaga0Tateaki Naito1Hisao Imai2Madoka Kimura3Satoru Miura4Hisashi Tanaka5Takuro Mizukami6Akira Imoto7Chihiro Kondoh8Hiroyuki Okuyama9Makoto Ueno10Shinsuke Shiotsu11Toshimi Inano12Haruka Chitose13Noriatsu Tatematsu14Taro Okayama15Takako Mouri16Miwa Sugiyama17Katsuhiro Omae18Takanori Kawabata19Keita Mori20Koichi Takayama21Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East Kashiwa JapanCancer Supportive Care Center Shizuoka Cancer Center Shizuoka JapanDivision of Respiratory Medicine Gunma Prefectural Cancer Center Gunma JapanDepartment of Thoracic Oncology Osaka International Cancer Institute Osaka JapanDepartment of Internal Medicine Niigata Cancer Center Hospital Niigata JapanDepartment of Respiratory Medicine Hirosaki University Hirosaki JapanDepartment of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanSecond Department of Internal Medicine Osaka Medical and Pharmaceutical University Osaka JapanDepartment of Medical Oncology Toranomon Hospital Tokyo JapanDepartment of Medical Oncology Kagawa University Hospital Kagawa JapanDepartment of Gastroenterology Kanagawa Cancer Center Yokohama JapanDepartment of Respiratory Medicine Japanese red Cross Kyoto Daiichi Hospital Kyoto JapanDivision of Nutrition Shizuoka Cancer Center Shizuoka JapanNutrition Management Office National Cancer Center Hospital Tokyo JapanDepartment of Integrated Health Sciences Nagoya University Nagoya Aichi JapanDivision of Rehabilitation Medicine Shizuoka Cancer Center Shizuoka JapanGraduate School of Nursing Kyoto Prefectural University of Medicine Kyoto JapanDivision of Nursing Shizuoka Cancer Center Shizuoka JapanDepartment of Data Science National Cerebral and Cardiovascular Center Suita JapanDepartment of Data Science National Cerebral and Cardiovascular Center Suita JapanDepartment of Biostatistics, Clinical Research Support Center Shizuoka Cancer Center Shizuoka JapanDepartment of Pulmonary Medicine Kyoto Prefectural University of Medicine Kyoto JapanABSTRACT Background In our previous study (NEXTAC‐ONE), the Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) program (including home‐based exercise and branched‐chain amino acid‐containing supplements combined with nutritional counselling) was shown to potentially prevent low muscle mass‐related disability in elderly cancer patients. This randomized controlled trial (NEXTAC‐TWO) was conducted to elucidate whether the NEXTAC program prolongs disability‐free survival in elderly patients with advanced pancreatic or non‐small cell lung cancer. Methods This open‐label, multicentre, randomized phase II study was conducted at 15 Japanese hospitals. Patients aged ≥ 70 years, with pathologically proven advanced pancreatic or non‐small cell lung cancer, who were scheduled to undergo systemic chemotherapy for treatment‐naïve tumours were randomly assigned (1:1) to undergo observation or receive the NEXTAC program for 12 weeks. Randomization was performed by the minimization method, using performance status and types with cancer diagnosis and anticancer treatment as adjustment factors. The primary endpoint was disability‐free survival (period from randomization to the date patients were evaluated as needing care or death due to any cause). Key secondary endpoints were change in weight, muscle mass, physical activity, nutritional assessment, safety and survival. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000028801). Results From 2017 to 2019, 131 patients were enrolled and randomly assigned to NEXTAC (n = 66) or control arms (n = 65, median age 76.0 years). After randomization, two patients in the NEXTAC arm declined further participation. As a result, 64 patients (median age 75.5 years) received at least one session of the NEXTAC program. The completion rate of the planned exercise and nutrition consultation sessions was 98.4% in the NEXTAC arm. Of the 129 patients, 91 (71%) had a disability (44 in the NEXTAC arm; 47 in the control arm). In the primary analysis, median disability‐free survival periods were 478 days (95% confidence interval [CI], 358–576) in the NEXTAC arm and 499 days in the control arm (95% CI, 363–604), with no significant differences between them (p = 0.884). The hazard ratio for disability‐free survival in the NEXTAC arm compared with the control arm was 0.970 (95% CI 0.642–1.465). There were no differences in the secondary endpoints between the two arms. Conclusions The patients had good compliance with the 12‐week NEXTAC program but failed to show significant improvements in disability‐free survival as compared to observation alone. Further study on the progression of low muscle mass in the NEXTAC arm is needed.https://doi.org/10.1002/jcsm.13871cancer cachexiaelderlylow muscle massmultimodal interventionnon‐small cell lung cancerpancreatic cancer |
| spellingShingle | Shuichi Mitsunaga Tateaki Naito Hisao Imai Madoka Kimura Satoru Miura Hisashi Tanaka Takuro Mizukami Akira Imoto Chihiro Kondoh Hiroyuki Okuyama Makoto Ueno Shinsuke Shiotsu Toshimi Inano Haruka Chitose Noriatsu Tatematsu Taro Okayama Takako Mouri Miwa Sugiyama Katsuhiro Omae Takanori Kawabata Keita Mori Koichi Takayama A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) Journal of Cachexia, Sarcopenia and Muscle cancer cachexia elderly low muscle mass multimodal intervention non‐small cell lung cancer pancreatic cancer |
| title | A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) |
| title_full | A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) |
| title_fullStr | A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) |
| title_full_unstemmed | A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) |
| title_short | A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non‐Small Cell Lung Cancer (NEXTAC‐TWO) |
| title_sort | randomized trial of nutrition and exercise treatment in patients with pancreatic and non small cell lung cancer nextac two |
| topic | cancer cachexia elderly low muscle mass multimodal intervention non‐small cell lung cancer pancreatic cancer |
| url | https://doi.org/10.1002/jcsm.13871 |
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