UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054942 |
|---|---|
| Receipt number | R000062768 |
| Scientific Title | Effects of Neuromuscular Electrical Stimulation Therapy on Patients with Advanced Cancer: A Preliminary Study on Implementation Rate and Safety |
| Date of disclosure of the study information | 2024/07/14 |
| Last modified on | 2026/01/19 22:34:38 |
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Basic information
Public title
Effects of electrical stimulation therapy in patients with advanced cancer: A feasibility and safety study
Acronym
Effects of electrical stimulation therapy in patients with advanced cancer
Scientific Title
Effects of Neuromuscular Electrical Stimulation Therapy on Patients with Advanced Cancer: A Preliminary Study on Implementation Rate and Safety
Scientific Title:Acronym
Effects of Neuromuscular Electrical Stimulation Therapy on Patients with Advanced Cancer
Region
| Japan |
Condition
Condition
Patients aged 18 years or older with advanced or recurrent cancer.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of NMES in patients with cancer and its acceptance compared to conventional exercise therapy. Additionally, to verify the preventive effects of NMES on skeletal muscle atrophy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. NMES implementation rate
2. Adverse events (Myalgia,Purpura,Fatigue,Pain of skin) assessed using CTCAE v5.0
Key secondary outcomes
1. Knee extension strength
2. Quadriceps muscle thickness
3. Timed Up and Go (TUG) test
4. Five times chair stand test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention Group: In addition to following a standard exercise therapy programme similar to the control group, the NMES group will also receive NMES. The NMES treatment will be administered using the ESPURGE device (Ito Co., Ltd.). The electrode pads will be placed on the quadriceps muscles of both legs. The NMES treatment will be applied for 30 minutes per session, five days a week, for a total of 10 days. The frequency settings will be 50Hz and a pulse width of 200~300 usec.
Interventions/Control_2
Control Group: Based on the criteria for discontinuation of cancer rehabilitation and under the direction of a physician, the control group will focus on strength training, range of motion exercises, basic movement exercises, and activities of daily living training.
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
1. Patients aged 18 years or older with advanced or recurrent cancer (with evidence of locally advanced disease or histological, cytological, or radiological metastases).
2. Patients who have been provided with comprehensive information regarding their participation in the study and who have provided written consent to take part in the study of their own volition, having had sufficient time to consider the implications of their participation.
Key exclusion criteria
1. Presence of cancer metastases in the thigh area to be treated with NMES
2. Cognitive impairment that prevents understanding or compliance with physical function assessment or exercise instructions
3. Determination by treating physician that participation is inappropriate
4. Planned early discharge
5. Patient or family request to withdraw from the study
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Nakanishi |
Organization
Social Medical Corporation Yurin-kai, Higashiosaka Hospital
Division name
Rehabilitation Department
Zip code
5360005
Address
3-4-32 Chuo, Joto-ku, Osaka-shi, Osaka 536-0005, Japan
TEL
0669338133
riha@yurin.or.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Nakanishi |
Organization
Social Medical Corporation Yurin-kai, Higashiosaka Hospital
Division name
Rehabilitation Department
Zip code
5360015
Address
3-4-32 Chuo, Joto-ku, Osaka-shi, Osaka 536-0005, Japan
TEL
0669338133
Homepage URL
riha@yurin.or.jp
Sponsor or person
Institute
Social Medical Corporation Yurin-kai, Higashiosaka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Yurin-kai, Higashiosaka Hospital
Address
3-4-32 Chuo, Joto-ku, Osaka-shi, Osaka 536-0005, Japan
Tel
0669338133
asow6907@gmail.com
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 | 07 | Month | 14 | 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
58
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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062768
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/01/17 | 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/03/17 | 研究仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/03/17 | case.xlsx.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/62768
