UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056202 |
|---|---|
| Receipt number | R000064219 |
| Scientific Title | Effects of early physiotherapy intervention in elderly colorectal cancer patients on oxaliplatin-based chemotherapy- Feasibility Study- |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2026/02/22 16:34:06 |
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Basic information
Public title
Feasibility of early physiotherapy in elderly colorectal cancer patients on oxaliplatin-based chemotherapy.
Acronym
Early physiotherapy for elderly colorectal cancer patients on L-OHP therapy.
Scientific Title
Effects of early physiotherapy intervention in elderly colorectal cancer patients on oxaliplatin-based chemotherapy- Feasibility Study-
Scientific Title:Acronym
Feasibility of Early physiotherapy for elderly colorectal cancer patients on L-OHP therapy.
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and feasibility of home-based exercise for elderly colorectal cancer patients undergoing oxaliplatin-based chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of participation in rehabilitation sessions
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects aged 65 years and over who have been decided to receive oxaliplatin-based chemotherapy at the institution concerned and have visited the rehabilitation department.Regardless of gender and whether or not the cancer is a recurrence.
Key exclusion criteria
Subjects with communication difficulties, such as inability to understand the purpose of the study. Subjects with a history of previous chemotherapy treatment causing high frequency of peripheral neuropathy, such as platinum or taxane-based anticancer drugs.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Miyata |
Organization
NHO Tokyo Medical Center
Division name
Palliative care medicine and Caner rehabilitation
Zip code
152-8902
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
TEL
0334110111
kuma1mie2chibi3@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chieko |
| Middle name | |
| Last name | Miyata |
Organization
NHO Tokyo Medical Center
Division name
Palliative care medicine and Cancer rehabilitation
Zip code
152-8902
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
TEL
0334110111
Homepage URL
kuma1mie2chibi3@yahoo.co.jp
Sponsor or person
Institute
NHO Tokyo Medical Center
Institute
Department
Personal name
Chieko Miyata
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Tokyo Medical Centre Ethics Committee
Address
Higashigaoka 2-5-1, Meguro-ku, Tokyo
Tel
0334110111
kuma1mie2chibi3@yahoo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study. Method of recruitment: individuals who visited our institution between July 2021 and December 2024 and met the inclusion criteria. Primary endpoint: percentage of subjects attending rehabilitation sessions (percentage of subjects who were able to attend at least 3 out of 4 sessions). Secondary endpoints: severity of peripheral neuropathy, quality of life.
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064219
