![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Bone metastasis | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
kmurofushi0918@gmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
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/ | ||||||
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |