UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038918 |
|---|---|
| Receipt number | R000044364 |
| Scientific Title | PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2023/06/21 10:37:12 |
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Basic information
Public title
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Acronym
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Scientific Title
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Scientific Title:Acronym
PHarmacological Audit study of Safety and Effectiveness in Real world (Phase R): Opioid for Cancer Dyspnea Study
Region
| Japan |
Condition
Condition
Cancer dyspnea
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the effectiveness and safety of systemic opioid therapy for dyspnea in cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patient whose dyspnea NRS score decrease 1 point or greater 72 hours after starting regular opioid.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Adult (20 year or older) cancer patient
2) Inpatient
3) Starting regular opioid (morphine, oxycodone, hydromorphone, or fentanyl) for dyspnea
Key exclusion criteria
1) Treatment for non-cancer etiology of dyspnea will be planed within 3 days.
2) Treatment which has potential of improving dyspnea drastically will be planed within 3 days.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kobe University
Division name
Department of Palliative Medicine
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ward, Kobe
TEL
0783826531
ikagoro@pop06.odn.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kobe University
Division name
Department of Palliative Medicine
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ward, Kobe
TEL
0783826531
Homepage URL
ikagoro@pop06.odn.ne.jp
Sponsor or person
Institute
Konan Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Konan Medical Center
Address
1-15-6 Kamokogahara
Tel
0788512161
ikagoro@pop06.odn.ne.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
東北大学病院（宮城県）、国立がん研究センター東病院（千葉県）、国立がんセンター中央病院（東京都）、都立駒込病院（東京都）、帝京大学病院（東京都）、聖隷三方原病院（静岡県）、小牧市民病院（愛知県）、大阪医療センター（大阪府）、近畿中央呼吸器センター（大阪府）、甲南医療センター（兵庫県）、神戸大学病院（兵庫県）、飯塚病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0885392423000040
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0885392423000040
Number of participants that the trial has enrolled
402
Results
The mean change in dyspnea NRS after 24, 48, and 72 hours of regular opioid use was 68.8% (95%CI: 0.63-0.74), 75.7% (95%CI: 0.70-0.81), and 82.1% (95%CI: 0.76 -The mean change in dyspnea NRS after initiation of regular opioid therapy was 1.73 (95%CI: 1.46-1.99), 1.99 (95%CI: 1.71 -2.28), 2.47 (95%CI: 2.13-2.82), respectively.
Results date posted
| 2023 | Year | 06 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 79.4 (SD: 12.6)years, 54.7% were male, and the most common primary cancer site was lung. More than half (51.5%)had lung metastases and 63.2% were complicated with pleural effusion. The majority (59.7%) were ECOG PS 4 and 46.3% were given a CPS of days. Opioid naive patients accounted for 55.7% of participants. For opioid tolerant patients, the mean baseline opioid dose was 55.7 mg per day of oral morphine equivalent. The majority (83.3%) of participants used supplemental oxygen or high flow nasal cannula.
Participant flow
In total 402 patients were enrolled. Of those, 375 at T1, 330 at T2 and 286 at T3 were evaluated.
Adverse events
The most common TEAE was somnolence with an incidence of 25.9%, 30.3%, and 29.4% at T1, T2, and T3, respectively. Of those, the rates of severe AE (grade 3 or more) were 8.0%, 11.5%, and 12.6% at T1, T2, and T3, respectively. Approximately 5% and 15% of participants developed nausea and delirium respectively at each evaluation time points. Of those, the rates of severe were approximately 1% and 4%, respectively at each evaluation time points. Other severe AEs were found 4 (respiratory failure, hypoxemia, liver failure, and fracture, each for one case) at T1 and 3 (2 cases of respiratory failure and one apnea) at T2.
Outcome measures
The proportion of responders by NRS definition were 68.8% (95%CI: 0.63, 0.74) at T1, 75.7% (95%CI: 0.70, 0.81) at T2, and 82.1% (95%CI: 0.76, 0.87) at T3. The mean differences in dyspnea NRS from baseline were 1.73 (95%CI: 1.46, 1.99) at T1, 1.99 (95%CI: 1.71, 2.28) at T2, and 2.47 (95%CI:2.13, 2.82) at T3, with a statistically significant difference at all three evaluation time points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 07 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Registry of the data from daily clinical practice. Observation period will be 72 hrs period after starting regular opioid for cancer dyspnea.
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044364
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