{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:26:14Z","timestamp":1789565174002,"version":"build-2803163510"},"reference-count":29,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,6,16]],"date-time":"2025-06-16T00:00:00Z","timestamp":1750032000000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In our previous study (NEXTAC\u2010ONE), the Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) program (including home\u2010based exercise and branched\u2010chain amino acid\u2010containing supplements combined with nutritional counselling) was shown to potentially prevent low muscle mass\u2010related disability in elderly cancer patients. This randomized controlled trial (NEXTAC\u2010TWO) was conducted to elucidate whether the NEXTAC program prolongs disability\u2010free survival in elderly patients with advanced pancreatic or non\u2010small cell lung cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This open\u2010label, multicentre, randomized phase II study was conducted at 15 Japanese hospitals. Patients aged \u2265 70\u2009years, with pathologically proven advanced pancreatic or non\u2010small cell lung cancer, who were scheduled to undergo systemic chemotherapy for treatment\u2010na\u00efve tumours were randomly assigned (1:1) to undergo observation or receive the NEXTAC program for 12\u2009weeks. 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\u2010free 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From 2017 to 2019, 131 patients were enrolled and randomly assigned to NEXTAC (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200966) or control arms (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200965, median age 76.0\u2009years). After randomization, two patients in the NEXTAC arm declined further participation. As a result, 64 patients (median age 75.5\u2009years) 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\u2010free survival periods were 478\u2009days (95% confidence interval [CI], 358\u2013576) in the NEXTAC arm and 499\u2009days in the control arm (95% CI, 363\u2013604), with no significant differences between them (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.884). The hazard ratio for disability\u2010free survival in the NEXTAC arm compared with the control arm was 0.970 (95% CI 0.642\u20131.465). There were no differences in the secondary endpoints between the two arms.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The patients had good compliance with the 12\u2010week NEXTAC program but failed to show significant improvements in disability\u2010free survival as compared to observation alone. Further study on the progression of low muscle mass in the NEXTAC arm is needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcsm.13871","type":"journal-article","created":{"date-parts":[[2025,6,16]],"date-time":"2025-06-16T12:38:44Z","timestamp":1750077524000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["A Randomized Trial of Nutrition and Exercise Treatment in Patients With Pancreatic and Non\u2010Small Cell Lung Cancer (NEXTAC\u2010TWO)"],"prefix":"10.1002","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9496-3278","authenticated-orcid":false,"given":"Shuichi","family":"Mitsunaga","sequence":"first","affiliation":[{"name":"Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East  Kashiwa Japan"},{"name":"Division of Biomarker Discovery, Exploratory Oncology Research and Clinical Trial Center National Cancer Center  Kashiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4047-2929","authenticated-orcid":false,"given":"Tateaki","family":"Naito","sequence":"additional","affiliation":[{"name":"Cancer Supportive Care Center Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisao","family":"Imai","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine Gunma Prefectural Cancer Center  Gunma Japan"},{"name":"Department of Respiratory Medicine, International Medical Center Saitama Medical University  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madoka","family":"Kimura","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Osaka International Cancer Institute  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Miura","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Niigata Cancer Center Hospital  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Hirosaki University  Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuro","family":"Mizukami","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology St. Marianna University School of Medicine  Kawasaki Japan"},{"name":"Department of Medical Oncology NTT Medical Center  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Imoto","sequence":"additional","affiliation":[{"name":"Second Department of Internal Medicine Osaka Medical and Pharmaceutical University  Osaka Japan"},{"name":"Department of Internal Medicine Aoyama Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chihiro","family":"Kondoh","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Toranomon Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Okuyama","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kagawa University Hospital  Kagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Ueno","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Kanagawa Cancer Center  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinsuke","family":"Shiotsu","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Japanese red Cross Kyoto Daiichi Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimi","family":"Inano","sequence":"additional","affiliation":[{"name":"Division of Nutrition Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haruka","family":"Chitose","sequence":"additional","affiliation":[{"name":"Nutrition Management Office National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriatsu","family":"Tatematsu","sequence":"additional","affiliation":[{"name":"Department of Integrated Health Sciences Nagoya University  Nagoya Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Okayama","sequence":"additional","affiliation":[{"name":"Division of Rehabilitation Medicine Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takako","family":"Mouri","sequence":"additional","affiliation":[{"name":"Graduate School of Nursing Kyoto Prefectural University of Medicine  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miwa","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Division of Nursing Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuhiro","family":"Omae","sequence":"additional","affiliation":[{"name":"Department of Data Science National Cerebral and Cardiovascular Center  Suita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takanori","family":"Kawabata","sequence":"additional","affiliation":[{"name":"Department of Data Science National Cerebral and Cardiovascular Center  Suita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keita","family":"Mori","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Clinical Research Support Center Shizuoka Cancer Center  Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Takayama","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine Kyoto Prefectural University of Medicine  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,16]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"National Cancer Center.Cancer Registry and Statistics. Cancer Information Service National Cancer Center Japan (Vital Statistics of Japan)accessed April 3 2024 [Japanese]https:\/\/ganjohojp\/reg_stat\/statistics\/dl\/."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.archger.2014.04.016"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0139749"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-017-3562-4"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12206"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1994.03520130074036"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.5616"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70218-7"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12402"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu086"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-020-05346-8"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12201"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12351"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-019-5762-6"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198311173092005"},{"key":"e_1_2_9_17_1","volume-title":"TNM Classification of Malignant Tumours","author":"Brierley J.","year":"2017"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/geronj\/49.2.M85"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1139\/H08\u2010075"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0899-9007(98)00171-3"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clnu.2020.04.008"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.63.6043"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.3109\/0284186X.2014.953259"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afy169"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/57.6.845"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00421\u2010017\u20103552\u2010x"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.5616"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70055-X"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31128"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32406"}],"container-title":["Journal of Cachexia, Sarcopenia and Muscle"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcsm.13871","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,25]],"date-time":"2025-06-25T06:24:25Z","timestamp":1750832665000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcsm.13871"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":29,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/jcsm.13871"],"URL":"https:\/\/doi.org\/10.1002\/jcsm.13871","archive":["Portico"],"relation":{},"ISSN":["2190-5991","2190-6009"],"issn-type":[{"value":"2190-5991","type":"print"},{"value":"2190-6009","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2024-10-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e13871"}}