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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047662
Receipt No. R000054345
Scientific Title Heart rate variability-based method for objectively evaluating bone metastasis pain: A pilot study
Date of disclosure of the study information 2022/05/15
Last modified on 2022/05/06

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Basic information
Public title Heart rate variability-based method for objectively evaluating bone metastasis pain: A pilot study
Acronym Heart rate variability-based method for objectively evaluating bone metastasis pain: A pilot study
Scientific Title Heart rate variability-based method for objectively evaluating bone metastasis pain: A pilot study
Scientific Title:Acronym Heart rate variability-based method for objectively evaluating bone metastasis pain: A pilot study
Region
Japan

Condition
Condition Bone metastasis
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to evaluate the efficacy of HRV as an objective assessment method for pain caused by bone metastasis, which is the leading cause of cancer-associated pain.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between pain evaluation and autonomic nervous activity (LF / HF, HF, total power) due to heart rate variability
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Obtaining heart beat intervals during 24 h
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 i) pathological diagnosis of cancer; ii) no bone metastasis causing severe pain other than the radiation field; iii) expected prognosis of 3 months or longer; and iv) data available on self-evaluation of pain, anxiety, and depression
Key exclusion criteria RRI could not be accurately evaluated due to arrhythmia or pacemaker, who had psychiatric comorbidities, such as depression or anxiety disorder, or impaired cognitive function, or bone fractures and strong nerve infiltration caused by bone metastasis.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name Nemoto
Last name Murofushi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Radiation Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL 03-3823-2101
Email kmurofushi0918@gmail.com

Public contact
Name of contact person
1st name Keiko
Middle name Nemoto
Last name Murofushi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Radiation Oncology
Zip code 113-8677
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL 03-3823-2101
Homepage URL https://www.cick.jp/
Email kmurofushi0918@gmail.com

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

Funding Source
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization Local Government
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 kmurofushi0918@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
2022 Year 05 Month 15 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 11
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
2020 Year 07 Month 17 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2020 Year 07 Month 21 Day
Last follow-up date
2021 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 06 Day
Last modified on
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054345

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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