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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036771
Receipt No. R000041895
Scientific Title A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Date of disclosure of the study information 2019/05/16
Last modified on 2019/05/16

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Basic information
Public title A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Acronym A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Scientific Title A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Scientific Title:Acronym A pilot study to explore efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Region
Japan

Condition
Condition advanced or recurrenced lung and pancreatic cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Explore the efficacy of outpatient cancer rehabilitation for advanced lung or pancreatic cancer under palliative chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes SPPB(Short Physical Performance Battery)
Key secondary outcomes one leg standinf time
incidence rate of sarcopenia
lean body mass
physical function
nutritional status
quality of life
survival
safety
toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) newly diagnosed LC/pancreatic cancer in stage III, IV, or post-operative recurrence.
2) >=20 years old
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) full count of mKatz index
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)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Utae
Middle name
Last name Katsushima
Organization Kansai Electric Power Hospital
Division name Department of Oncology
Zip code 553-0003
Address 2-1-7Fukushima,Fukushima-ku,Osaka
TEL 0664585821
Email katsushima.utae@d2.kepco.co.jp

Public contact
Name of contact person
1st name Utae
Middle name
Last name Katsushima
Organization Kansai Electric Power Hospital
Division name Department of Oncology
Zip code 553-0003
Address 2-1-7Fukushima,Fukushima-ku,Osaka
TEL 0664585821
Homepage URL
Email katsushima.utae@d2.kepco.co.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization Kansai Electric Power Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kansai Electric Power Hospital
Address 2-1-7Fukushima,Fukushima-ku,Osaka
Tel 0664585821
Email katsushima.utae@d2.kepco.co.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 関西電力病院(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 16 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
Results
Results date posted
Results Delayed
Results Delay Reason
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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 10 Day
Date of IRB
2019 Year 05 Month 10 Day
Anticipated trial start date
2019 Year 05 Month 16 Day
Last follow-up date
2024 Year 05 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041895

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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