A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer

Conditions

Non-small-cell lung and pancreatic cancer

Shuichi Mitsunaga, Tateaki Naito, Hisao Imai, Madoka Kimura, Satoru Miura et al. (22 authors)

Journal of Cachexia Sarcopenia and Muscle2025-06-013 citations

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 et al. (26 authors)

BMC Cancer2019-05-3155 citations

10.1186/s12885-019-5762-6

A randomized phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small cell lung or pancreatic cancer: The NEXTAC-TWO study.

Satoru Miura, Tateaki Naito, Shuichi Mitsunaga, Katsuhiro Omae, Keita Mori et al. (17 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.tps10131

Interventions

1. nutritional couseling 2. home-based exercise intervention 3. physical activity intervention Usual care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) >=70 years old and ECOG-PS 0-2 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) More than 3 months of survival was expected

Exclusion criteria

Exclusion criteria: 1) Having disabilities according to the modified KATZ index 2) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc) 3) Having difficulties in swallowing, digesting, and absorbing food

Design outcomes

Primary

Measure	Time frame
Disability-free survival	—

Secondary

Measure	Time frame
1. lean body mass 2. physical function 3. nutritional status 4. quality of life 5. safety	—

Countries

Japan

Contacts

Public ContactTateaki Naito

Shizuoka Cancer Center Division of thoracic oncology

t.naito@scchr.jp055-989-5222

Outcome results

None listed