UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047662 |
|---|---|
| Receipt number | 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 | 2024/03/25 13:52:51 |
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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
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/
kmurofushi0918@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
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)
the Secom Science and Technology Foundation
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
| 2022 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.21873/invivo.13166
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.21873/invivo.13166
Number of participants that the trial has enrolled
11
Results
HRV measurements can objectively evaluate pain due to bone metastasis. However, we must consider that the effects of mental status, such as depression, on LF/HF also affect HRV in patients with cancer with mild pain.
Results date posted
| 2024 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 07 | Day |
Baseline Characteristics
Between July 2020 and July 2021, 11 patients were enrolled. The median age of the patients was 65 years (range=50-83 years). Eight patients were men and three were women. Six of the 11 patients received radiotherapy for pelvic bone metastasis, four for spinal metastasis, and two for metastasis in other regions, such as the rib and scapula. One patient underwent irradiation for pelvic and spinal metastases simultaneously. Seven of the 11 patients were treated with SBRT.
Participant flow
In four of the 11 patients, who received a dose of 20.0-24.0 Gy in 1-2 fractions, NRS, HADS, and heart rate intervals were obtained at the start of radiotherapy and 3-5 weeks after the completion of radiotherapy. Of the patients, one could not be assessed at completion of radiotherapy because of patient refusal, another could not visit our hospital 3-5 weeks after the completion of radiotherapy because of deterioration of his general condition, and another could not be assessed using the HADS 3-5 weeks after the completion of radiotherapy. Therefore, 27 samples for NRS and heart rate intervals and 26 samples for HADS were analysed.
Adverse events
None
Outcome measures
The median average, maximum, and minimum NRS scores were 5 (range=2-10), 6 (range=2-10), and 3 (range=0-8), respectively. In the HADS assessment, the median anxiety and depression scores were 8 (range=1-13) and 8 (range=2-21), respectively. The mean HF, LF/HF, and TP over approximately 24 h were 0.52 ms2 (standard deviation, SD=1.66 ms2), 2.45 (SD=1.20), and 0.94 ms2 (SD=2.41 ms2), respectively.
There was no significant relationship between mean LF/HF and anxiety score, mean HF over approximately 24 h and anxiety score, and mean HF and depression score (r<0.001, p=0.99; r=0.047, p=0.829; and r=0.050, p=0.815, respectively). However, mean LF/HF over approximately 24 h tended to be slightly associated with depression score in the HADS (r=0.32, p=0.13). For all samples, the NRS score had no significant relationship with the mean LF/HF and HF (r=0.094, p=0.66 and r=0.071, p=0.74, respectively). For samples with NRS >=4, NRS score was significantly associated with LF/HF (r=0.58, p=0.03), but not with HF (r=0.37, p=0.197).
Although the heart rate during physical activity was slightly higher than that at rest (p=0.073), the mean LF/HF ratio at rest was significantly higher than that during physical activity (p=0.024). At rest, mean LF/HF was not associated with NRS score for all samples or those with NRS >=4 (r=0.11, p=0.61 and r=0.21, p=0.49, respectively). Excluding those with a HADS depression score >=7 in an NRS score 1-3, there was a trend for a positive correlation between the NRS score and the mean LF/HF (r=0.51, p=0.07).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054345
