UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039147 |
|---|---|
| Receipt number | R000044647 |
| Scientific Title | A multicenter prospective observational study on the structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2025/01/27 16:16:10 |
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Basic information
Public title
A multicenter prospective observational study on the structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients
Acronym
A multicenter prospective observational study on the structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients
Scientific Title
A multicenter prospective observational study on the structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients
Scientific Title:Acronym
A multicenter prospective observational study on the structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the practice of a structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients
Basic objectives2
Others
Basic objectives -Others
To explore outcomes of a structured parenteral opioid intervention for dyspnea in terminally-ill cancer patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of patients who receive a structured parenteral opioid intervention at 24 (18-30) hours after the initiation of the intervention for dyspnea
Key secondary outcomes
The percentage of the utilization of a structured parenteral opioid intervention, achievement of treatment goals, contents of concurrent treatment such as increase and/or switching of opioids and benzodiazepines, dyspnea intensity, communication capacity and consciousness level, adverse events and dose-limiting toxicities, etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized patients with the age of 18 or greater
2) Patients diagnosed with locally advanced or metastatic cancer
3) Patients started on the continuous administration of parenteral opioids for dyspnea (IPOS/STAS of 2 or greater)
4) Patients receiving care by palliative care specialist(s) at a palliative care unit or palliative care team
5) ECOG Performance Status 3 or 4
6) Communication Capacity Scale (CCS), item 4 of 2 or lower
Key exclusion criteria
1) Patients who will receive treatent for dyspnea that clearly has no direct pathophysiological association with cancer
2) Patients who are planning to undergo interventions that would change symptom intensity during a short period within 3 days.
3) Patient or family decline to participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Mori |
Organization
Seirei Mikatahara General Hospital
Division name
Palliative and Supportive Care Division
Zip code
433-8558
Address
3453 Mikataharacho, Kita-ku, Hamamatsu
TEL
0534361251
masanori.mori@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Mori |
Organization
Seirei Mikatahara General Hospital
Division name
Palliative and Supportive Care Division
Zip code
433-8558
Address
3453 Mikataharacho, Kita-ku, Hamamatsu
TEL
0534361251
Homepage URL
masanori.mori@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour, and Welfare
Japan Hospice Palliative Care Foundation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Mikatahara General Hospital
Address
3453 Mikataharacho, Kita-ku, Hamamatsu
Tel
0534361251
masanori.mori@sis.seirei.or.jp
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
| 2020 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36259645/
Number of participants that the trial has enrolled
108
Results
All 108 patients received algorithm-based pharmacological treatment. Among 96 and 87 patients who were alive at 24 and 48 h, respectively, 96 (100%) and 82 (94%) continued to receive the algorithm treatment, respectively, and 66 (69%) and 64 (74%) achieved the treatment goals, respectively. Mean dyspnea NRS scores significantly reduced from 7.3 at the baseline to 4.9 at 24 h (n=72; p<0.001), and 7.2 at the baseline to 4.6 at 48 h (n=55; p<0.001). Most adverse events were mild to moderate.
Results date posted
| 2025 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 72 (standard deviation [SD], 12), 43 (40%) patients had lung cancer, 59 (55%) had lung metastases, and 85 (79%) had an ECOG PS of 4.
Participant flow
A total of 108 patients were enrolled and analyzed.
Adverse events
Most adverse events were mild to moderate (CTCAE=1 and 2), including nausea and delirium.
Outcome measures
The primary outcome was the proportion of adherence to the treatment algorithm over 24 h (predefined goal, 70%). We evaluated the adherence, goal achievement, and dyspnea level with a numerical rating scale (NRS), as well as adverse events over 48 h.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Seirei Mikatahara General Hospital serves as the central site of this multicenter study.
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044647
