UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056201 |
|---|---|
| Receipt number | R000057804 |
| Scientific Title | Home-based exercise for cancer patients with chemotherapy-induced peripheral neuropathy-Feasibility Study- |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2025/11/28 01:16:50 |
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Basic information
Public title
Home-based exercise for cancer patients with chemotherapy-induced peripheral neuropathy-Feasibility Study-
Acronym
Home-based exercise for CIPN
Scientific Title
Home-based exercise for cancer patients with chemotherapy-induced peripheral neuropathy-Feasibility Study-
Scientific Title:Acronym
Home-based exercise for CIPN-Feasibility Study-
Region
| Japan |
Condition
Condition
Chemotherapy-induced peripheral neuropathy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chemotherapy-induced peripheral neuropathy is a frequent adverse event, but there is no established treatment method yet. This study examines the tolerability of home-based exercise therapy in cancer patients with chemotherapy-induced peripheral neuropathy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of participation in outpatient rehabilitation sessions by physical therapists and occupational therapists
Key secondary outcomes
Home exercise status
Physical function
sensory function
ADL
manual dexterity
QOL
Chemotherapy Compliance
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
Cancer patients undergoing outpatient treatment at National Hospital Organization Tokyo Medical Center.
Patients 20 years of age or older who have visited the outpatient clinic for rehabilitation for chemotherapy-induced peripheral neuropathy.
Patients who are able to undergo physical function assessment.
Patients who have given consent to participate in the study.
Key exclusion criteria
Patients with communication difficulties, such as inability to understand the purpose of the study
Patients with pre-existing or coexisting cerebrospinal and psychiatric disorders
Patients who received only speech therapy
Patients with reasons deemed inappropriate by the physician in charge
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 and cancer rehabilitation
Zip code
152-8902
Address
Meguro-ku, Higashigaoka2-5-1, Tokyo
TEL
03-3411-0111
kuma1mie2chibi3@hosp.go.jp
Public contact
Name of contact person
| 1st name | CHIEKO |
| Middle name | |
| Last name | MIYATA |
Organization
NHO Tokyo Medical Center
Division name
Palliative care and cancer rehabilitation
Zip code
152-8902
Address
Meguro-ku, Higashigaoka2-5-1, Tokyo
TEL
03-3411-0111
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center
Address
Meguro-ku, Higashigaoka2-5-1, Tokyo
Tel
03-3411-0111
rinrijm@hosp.ncgm.go.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
Published
Result
URL related to results and publications
DOI: https://www.doi.org/10.1186/s13102-025-01223-1
Number of participants that the trial has enrolled
25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 02 | Day |
Baseline Characteristics
Participant flow
Adverse events
No adverse events directly attributable to the rehabilitation were observed.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 15 | Day |
Other
Other related information
Study design: prospective cohort study. Methods of recruitment: patients who visited our institution between December 2022 and February 2024 and met the selection criteria. Primary endpoints: percentage of participation in outpatient rehabilitation sessions, drop-out rate from rehabilitation. Secondary endpoints: physical function, activities of daily living, quality of life and cancer treatment compliance.
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057804
