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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044203
Receipt No. 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 2021/10/11

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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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with severe pain of NRS5 or more
2. patients aged 20 years or over and under 75 years 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
Email murofushi@pmrc.tsukuba.ac.jp

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
Email murofushi@pmrc.tsukuba.ac.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

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
Email murofushi@pmrc.tsukuba.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 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)

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 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Last registration date: 2022/12/31

Management information
Registered date
2021 Year 05 Month 13 Day
Last modified on
2021 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050471

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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