UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044203 |
|---|---|
| Receipt number | R000050471 |
| Scientific Title | Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis, multicenter prospective observational study. |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/02/02 14:15:13 |
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Basic information
Public title
Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis.
Acronym
Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis.
Scientific Title
Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis, multicenter prospective observational study.
Scientific Title:Acronym
Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis, multicenter prospective observational study.
Region
| Japan |
Condition
Condition
Bone metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation for efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between autonomic nerve activity (LF/HF, HF and total power) evaluated by heart rate variability and pain assessment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with severe pain of NRS4 or more
2. Patients aged 20 years or over when acquiring informed consent
3. No metastatic bone tumors other than in radiation field that could cause severe pain
4. Patients with expected prognosis of 3 months or more
5. Patients with ability to assess pain, anxiety and depression by themselves
6. Patients received sufficient explanation before participating in this study, and obtained written consent by the patient himself / herself with sufficient understanding
Key exclusion criteria
1. Patients whose RR interval cannot be accurately evaluated due to arrhythmia
2. Patients with psychiatric complications such as depression and anxiety disorders
3. Patients with apparently poor cognitive function
4. Metastatic bone tumors with fracture or strong nerve invasion (patients who are difficult to obtain the pain-relieving effect by radiation)
5. Patients with retinopathy, nephropathy or neuropathy caused by diabetes
6. Patients who are not expected to be outpatients at one month after radiation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Murofushi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Radiation Oncology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
kmurofushi0918@gmail.com
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Murofushi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Radiation Oncology
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
Homepage URL
kmurofushi0918@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
SECOM Science and Technology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18-22, Honkomagome, Bunkyo-ku, Tokyo
Tel
03-3823-2101
km_rinri@tmhp.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
がん・感染症センター都立駒込病院（東京都）、茨城県立中央病院（茨城県）、九州大学病院（福岡県）、国際医療福祉大学成田病院（千葉県）、埼玉医科大学国際医療センター（埼玉県）、筑波大学附属病院（茨城県）、日本赤十字医療センター（東京都）、兵庫県立がんセンター（兵庫県）、神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2001 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Last registration date: 2023/6/30
Management information
Registered date
| 2021 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050471
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| Registered date | File name |
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| Registered date | File name |
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