UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044839 |
|---|---|
| Receipt number | R000051214 |
| Scientific Title | A prospective study of various functional assessments of the elderly and adverse events, persistence, and treatment effects of cancer chemotherapy |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/13 09:08:35 |
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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 | Obstetrics 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
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
21p2001@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051214
