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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name