UMIN-CTR Clinical Trial

Basic information
Public title	A Feasibility study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Acronym	NEXTAC-ONE study
Scientific Title	A Feasibility study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Scientific Title:Acronym	NEXTAC-ONE study
Region	Japan

Condition
Condition	Non-small-cell lung and pancreatic cancer
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility and safety of multimodal intervention (exercise, nutrition, and lifestyle intervention) in patients with advanced cancer receiving chemotherapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	attendance rate for exercise and nutritional sessions in 8 weeks
Key secondary outcomes	safety, adverse events, compliance

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	early multimodal intervention (nutritional intervention, home-based muscle training, and lifestyle intervention to promote physical activity)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Takayama
Organization	Kyoto Prefectual University of Medicine
Division name	Department of Respirology
Zip code	602-8566
Address	Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
TEL	075-251-5513
Email	takayama@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Tateaki Middle name Last name Naito
Organization	Shizuoka Cancer Center
Division name	Division of Thoracic Oncology
Zip code	411-8777
Address	1007 Shimonagakubo, Nagaizumi, Shizuoka, 411-8777, JAPAN
TEL	055-989-5222
Homepage URL
Email	t.naito@scchr.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shizuoka Cancer Center Institutional Review Board
Address	1007 Shimonagakubo, Nagaizumi, Shizuoka, 411-8777, JAPAN
Tel	0559895222
Email	t.naito@scchr.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/30334618/
Publication of results	Partially published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pubmed/30334618
Number of participants that the trial has enrolled	30
Results	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.
Results date posted	2021 Year 02 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	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
Participant flow	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	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).
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
Date of IRB	2016 Year 07 Month 04 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 17 Day
Last modified on	2021 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026753