Unique ID issued by UMIN | UMIN000023207 |
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Receipt number | R000026753 |
Scientific Title | A Feasibility study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2021/02/23 18:46:37 |
A Feasibility study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
NEXTAC-ONE study
A Feasibility study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
NEXTAC-ONE study
Japan |
Non-small-cell lung and pancreatic cancer
Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology |
Malignancy
NO
To evaluate feasibility and safety of multimodal intervention (exercise, nutrition, and lifestyle intervention) in patients with advanced cancer receiving chemotherapy
Safety
attendance rate for exercise and nutritional sessions in 8 weeks
safety, adverse events, compliance
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food | Behavior,custom |
early multimodal intervention (nutritional intervention, home-based muscle training, and lifestyle intervention to promote physical activity)
70 | years-old | <= |
Not applicable |
Male and Female
1) >=70 years old and ECOG-PS 0-1
2) newly diagnosed NSCLC/pancreatic cancer in stage III, IV, or post-operative recurrence.
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) Brathel index >= 95 points
6) More than 3 months of survival was expected
1) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc)
2) Having difficulties in swallowing, digesting, and absorbing food
30
1st name | Koichi |
Middle name | |
Last name | Takayama |
Kyoto Prefectual University of Medicine
Department of Respirology
602-8566
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
075-251-5513
takayama@koto.kpu-m.ac.jp
1st name | Tateaki |
Middle name | |
Last name | Naito |
Shizuoka Cancer Center
Division of Thoracic Oncology
411-8777
1007 Shimonagakubo, Nagaizumi, Shizuoka, 411-8777, JAPAN
055-989-5222
t.naito@scchr.jp
Japan Agency for Medical Research and Development
Japan Agency for Medical Research and Development
Japanese Governmental office
Shizuoka Cancer Center Institutional Review Board
1007 Shimonagakubo, Nagaizumi, Shizuoka, 411-8777, JAPAN
0559895222
t.naito@scchr.jp
NO
京都府立医科大学大学(京都府)、静岡県立静岡がんセンター(静岡県)、新潟県立がんセンター(新潟県)、国立がん研究センター東病院(千葉県)
2016 | Year | 08 | Month | 01 | Day |
https://pubmed.ncbi.nlm.nih.gov/30334618/
Partially published
https://www.ncbi.nlm.nih.gov/pubmed/30334618
30
Conclusions: The early induction of multimodal interventions showed excellent compliance and safety in elderly patients with newly diagnosed pancreatic and non-small-cell lung cancer receiving concurrent chemotherapy. We are now conducting a randomized phase II study to measure the impact of these interventions on functional prognosis.
2021 | Year | 02 | Month | 23 | Day |
The median patient age was 75 years (range, 70-84). Twelve patients (40%) were cachectic at baseline. Twenty-nine patients attended >=4 of the six planned sessions (96.7%, 95% confidence interval, 83.3 to 99.4). One patient dropped out due to deteriorating health status
This was a multicentre prospective single-arm study. We recruited 30 of 46 screened patients aged >=70 years scheduled to receive first-line chemotherapy for newly diagnosed, advanced pancreatic, or non-small-cell lung cancer.
Adverse events possibly related to the NEXTAC programme were observed in five patients and included muscle pain (Grade 1 in two patients), arthralgia (Grade 1 in one patient), dyspnoea on exertion (Grade 1 in one patient), and plantar aponeurositis (Grade 1 in one patient).
Twelve patients (40%) were cachectic at baseline. Twenty-nine patients attended >=4 of the six planned sessions (96.7%, 95% confidence interval, 83.3 to 99.4). One patient dropped out due to deteriorating health status. The median proportion of days of compliance with supplement consumption and exercise performance were 99% and 91%, respectively.
Completed
2016 | Year | 07 | Month | 04 | Day |
2016 | Year | 07 | Month | 04 | Day |
2016 | Year | 08 | Month | 01 | Day |
2019 | Year | 09 | Month | 30 | Day |
2016 | Year | 07 | Month | 17 | Day |
2021 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026753
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