UMIN-CTR Clinical Trial

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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