UMIN-CTR Clinical Trial

Basic information
Public title	Survey on Functional Assessment and Cancer Chemotherapy in the Elderly
Acronym	Physical Fitness and Adverse Effects of Cancer Chemotherapy in the Elderly
Scientific Title	A prospective study of various functional assessments of the elderly and adverse events, persistence, and treatment effects of cancer chemotherapy
Scientific Title:Acronym	A Prospective Study on Functional Assessment and Cancer Chemotherapy Practice in the Elderly
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Nephrology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study will conduct functional assessment of the elderly in patients with malignant tumors undergoing chemotherapy to investigate the impact of chemotherapy on side effects and treatment outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate the functional assessment of the elderly and the incidence of side effects during the first 6 months of treatment. Elderly functional assessment will evaluate VES13, cognitive function, such as G8
Key secondary outcomes	Type of side effect, reason for dose reduction, relative dose intensity

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing first-line chemotherapy or first-line. recurrent chemotherapy for solid cancer Patients with Eastern Cooperative Oncology Group Performance Status 4. Patients for whom free and voluntary consent to participate in research can be obtained in writing from the individual. Patients aged 18 years or older at the time of obtaining consent.
Key exclusion criteria	Patients with CTCAE grade 2 or higher side effects prior to chemotherapy administration. Patients who are unable to properly complete the elderly functional assessment chart(dementia, etc.) If a family member who lives with the respondent can answer the question, the respondent is not excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Junya Middle name Last name Sato
Organization	International University of Health and Welfare Hospital
Division name	Department of Pharmacy
Zip code	329-2763
Address	537-3,Iguchi,Nasushiobara-shi,Tochigi,329-2763 Japan
TEL	0287-37-2221
Email	junya.sato@iuhw.ac.jp

Public contact
Name of contact person	1st name Manami Middle name Last name Kazaoka
Organization	International University of Health and Welfare Hospital
Division name	Department of Pharmacy
Zip code	329-2763
Address	537-3,Iguchi,Nasushiobara-shi,Tochigi,329-2763 Japan
TEL	0287-37-2221
Homepage URL
Email	21p2001@g.iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare Hospital
Institute
Department

Funding Source
Organization	International University of Health and Welfare 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	International University of Health and Welfare Hospital
Address	537-3,Iguchi,Nasushiobara-shi,Tochigi,329-2763 Japan
Tel	0287-37-221
Email	junya.sato@iuhw.ac.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

Other administrative information
Date of disclosure of the study information	2021 Year 08 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
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	Preinitiation
Date of protocol fixation	2021 Year 07 Month 13 Day
Date of IRB	2021 Year 08 Month 01 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 01 Month 31 Day
Date trial data considered complete	2023 Year 01 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	This study is a prospective observational study that will accept entries until December 31, 2023.

Management information
Registered date	2021 Year 07 Month 13 Day
Last modified on	2021 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051214