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
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 nut...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-05-01
|
| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-019-5762-6 |
| _version_ | 1819110922790109184 |
|---|---|
| author | 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 Toshiaki Takahashi Tetsuya Tsuji Hideki Aragane Akio Inui Takashi Higashiguchi Koichi Takayama |
| author_facet | 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 Toshiaki Takahashi Tetsuya Tsuji Hideki Aragane Akio Inui Takashi Higashiguchi Koichi Takayama |
| author_sort | Satoru Miura |
| collection | DOAJ |
| description | 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. Trial registration Registered at August 23, 2017. Registry number: UMIN000028801. |
| first_indexed | 2024-12-22T03:49:25Z |
| format | Article |
| id | doaj.art-23ab2a263ae1478bbbcac019d360c3f6 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-22T03:49:25Z |
| publishDate | 2019-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-23ab2a263ae1478bbbcac019d360c3f62022-12-21T18:40:02ZengBMCBMC Cancer1471-24072019-05-0119111010.1186/s12885-019-5762-6A 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 protocolSatoru Miura0Tateaki Naito1Shuichi Mitsunaga2Katsuhiro Omae3Keita Mori4Toshimi Inano5Teiko Yamaguchi6Noriatsu Tatematsu7Taro Okayama8Ayumu Morikawa9Takako Mouri10Hisashi Tanaka11Madoka Kimura12Hisao Imai13Takuro Mizukami14Akira Imoto15Chihiro Kondoh16Shinsuke Shiotsu17Hiroyuki Okuyama18Makoto Ueno19Toshiaki Takahashi20Tetsuya Tsuji21Hideki Aragane22Akio Inui23Takashi Higashiguchi24Koichi Takayama25Department of Internal Medicine, Niigata Cancer Center HospitalDepartment of Thoracic Oncology, Shizuoka Cancer CenterDepartment of Hepatobiliary & Pancreatic Oncology, National Cancer Center Hospital EastDepartment of Clinical Biostatistics, Graduate School of Medicine, Kyoto UniversityClinical Research Center, Shizuoka Cancer CenterDivision of Nutrition, Shizuoka Cancer CenterDepartment of Health Sciences, Kyushu University Graduate School of Medical SciencesDepartment of Rehabilitation Medicine, National Cancer Center Hospital EastDivision of Rehabilitation Medicine, Shizuoka Cancer CenterDivision of Nursing, Shizuoka Cancer CenterDepartment of Pulmonary Medicine, Kyoto Prefectural University of MedicineDepartment of Respiratory Medicine, Hirosaki UniversityDepartment of Thoracic Oncology, Osaka International Cancer InstituteDivision of Respiratory Medicine, Gunma Prefectural Cancer CenterDepartment of Clinical Oncology, St. Marianna University School of MedicineSecond Department of Internal Medicine, Osaka Medical CollegeDepartment of Medical Oncology, Toranomon HospitalDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi HospitalDepartment of Clinical Oncology, Kagawa University HospitalDepartment of Gastroenterology, Kanagawa Cancer CenterDepartment of Thoracic Oncology, Shizuoka Cancer CenterDepartment of Rehabilitation Medicine, Keio University School of MedicineDepartment of Surgery, Aiseikai Yamashina HospitalPharmacological Department of Herbal Medicine, Graduate School of Medical and Dental Sciences, Kagoshima UniversityDepartment of Surgery and Palliative Medicine, Fujita Health University School of MedicineDepartment of Pulmonary Medicine, Kyoto Prefectural University of MedicineAbstract 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. Trial registration Registered at August 23, 2017. Registry number: UMIN000028801.http://link.springer.com/article/10.1186/s12885-019-5762-6CachexiaElderly patientsLung cancerPancreatic cancerMultimodal intervention |
| spellingShingle | 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 Toshiaki Takahashi Tetsuya Tsuji Hideki Aragane Akio Inui Takashi Higashiguchi Koichi Takayama 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 Cachexia Elderly patients Lung cancer Pancreatic cancer Multimodal intervention |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Cachexia Elderly patients Lung cancer Pancreatic cancer Multimodal intervention |
| url | http://link.springer.com/article/10.1186/s12885-019-5762-6 |
| work_keys_str_mv | AT satorumiura arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tateakinaito arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT shuichimitsunaga arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT katsuhiroomae arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT keitamori arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT toshimiinano arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT teikoyamaguchi arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT noriatsutatematsu arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tarookayama arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT ayumumorikawa arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takakomouri arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hisashitanaka arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT madokakimura arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hisaoimai arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takuromizukami arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT akiraimoto arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT chihirokondoh arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT shinsukeshiotsu arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hiroyukiokuyama arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT makotoueno arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT toshiakitakahashi arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tetsuyatsuji arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hidekiaragane arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT akioinui arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takashihigashiguchi arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT koichitakayama arandomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT satorumiura randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tateakinaito randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT shuichimitsunaga randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT katsuhiroomae randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT keitamori randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT toshimiinano randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT teikoyamaguchi randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT noriatsutatematsu randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tarookayama randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT ayumumorikawa randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takakomouri randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hisashitanaka randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT madokakimura randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hisaoimai randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takuromizukami randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT akiraimoto randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT chihirokondoh randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT shinsukeshiotsu randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hiroyukiokuyama randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT makotoueno randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT toshiakitakahashi randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT tetsuyatsuji randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT hidekiaragane randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT akioinui randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT takashihigashiguchi randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol AT koichitakayama randomizedphaseiistudyofnutritionalandexercisetreatmentforelderlypatientswithadvancednonsmallcelllungorpancreaticcancerthenextactwostudyprotocol |