UMIN-CTR Clinical Trial

Basic information
Public title	Characteristics of muscular function in cancer patients receiving the conservative therapy
Acronym	Characteristics of muscular function in cancer patients receiving the conservative therapy
Scientific Title	Characteristics of muscular function in cancer patients receiving the conservative therapy
Scientific Title:Acronym	Characteristics of muscular function in cancer patients receiving the conservative therapy
Region	Japan

Condition
Condition	1)Cancer patients receiving the conservative therapy 2)Community-dwelling elderly subjects
Classification by specialty	Hematology and clinical oncology Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1)To clarify the characteristic of physical function in cancer patients by comparing with community-dwelling elderly subjects 2)To clarify the effects of rehabilitation in cancer patients by measuring the longitudinal change of physical function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	skeletal muscle mass
Key secondary outcomes	grip strength knee extent strength physical activity 10-m walking test Timed up and go test Activity of Daily Living fatigue anxiety and depression self-efficacy Quality of Life

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Cancer patients receiving conservative therapy in the hospital,community-dwelling healthy subjects 2)Subjects who are possible to perform exercise and evaluation 3)Subjects who obtained consent by his/her own will
Key exclusion criteria	1)Subjects considered inappropriate by the doctor in charge or study investigator 2)Subjects with poor general status 3)Subjects with severe heart or respiratory disease,hepatic or renal failure 4)Subjects with cerebrovascular or orthopedic disease that have a great influence on the physical function 5)Subjects who are impossible to communicate and understand the purpose of study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuya Fukushima
Organization	Nagasaki University, Graduate School of Biomedical Science
Division name	Rehabilitation Science
Zip code
Address	1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, 852-8520, Japan
TEL	095-819-7919
Email	takuyafukushima321@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takuya Fukushima
Organization	Nagasaki University, Graduate School of Biomedical Science
Division name	Rehabilitation Science
Zip code
Address	1-7-1, Sakamoto, Nagasaki-shi, Nagasaki, 852-8520, Japan
TEL	095-819-7919
Homepage URL
Email	takuyafukushima321@yahoo.co.jp

Sponsor
Institute	Nagasaki University, Graduate School of Biomedical Science
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research, Scientific Research
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
Address
Tel
Email

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	長崎大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 18 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	Completed
Date of protocol fixation	2015 Year 08 Month 14 Day
Date of IRB	2015 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 08 Month 18 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	skeletal muscle mass grip strength knee extent strength physical activity 10-m walking test Timed up and go test Activity of Daily Living fatigue anxiety and depression self-efficacy Quality of Life

Management information
Registered date	2015 Year 08 Month 18 Day
Last modified on	2021 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021651