UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028801 |
|---|---|
| Receipt number | R000032961 |
| Scientific Title | A Randomized Phase II 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 | 2017/09/01 |
| Last modified on | 2023/02/25 10:01:41 |
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Basic information
Public title
A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Acronym
NEXTAC-TWO study
Scientific Title
A Randomized Phase II study of the nutritional and exercise treatment for the elderly patients with advanced non-small-cell lung and pancreatic cancer
Scientific Title:Acronym
NEXTAC-TWO 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 extend disability-free survival in elderly patients with advanced non-small cell and pancreatic cancer by early induction of multimodal care with nutritional and exercise intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Disability-free survival
Key secondary outcomes
1. lean body mass
2. physical function
3. nutritional status
4. quality of life
5. safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
1. nutritional couseling
2. home-based exercise intervention
3. physical activity intervention
Interventions/Control_2
Usual care
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 0-2
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
Key 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
Target sample size
130
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
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 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
t.naito@scchr.jp
Sponsor or person
Institute
Department of Respirology, Kyoto Prefectual University of Medicine
Institute
Department
Personal name
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 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
0559895222
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
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
131
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under review
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032961
