UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056675 |
|---|---|
| Receipt number | R000062805 |
| Scientific Title | Multicenter Prospective Observational Study to Investigate the Tolerability of Long-Term HFNC in Patients with Advanced Cancer and Poor Performance Status Experiencing Dyspnea at Rest |
| Date of disclosure of the study information | 2025/01/09 |
| Last modified on | 2025/01/09 17:20:41 |
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Basic information
Public title
Multicenter Prospective Observational Study to Investigate the Tolerability of Long-Term HFNC in Patients with Advanced Cancer and Poor Performance Status Experiencing Dyspnea at Rest
Acronym
CJLSG2302 Study
Scientific Title
Multicenter Prospective Observational Study to Investigate the Tolerability of Long-Term HFNC in Patients with Advanced Cancer and Poor Performance Status Experiencing Dyspnea at Rest
Scientific Title:Acronym
CJLSG2302 Study
Region
| Japan |
Condition
Condition
Patients who have received a pathological or clinical diagnosis of advanced cancer before registration
Patients with an ECOG PS of 3 or 4 (as determined by at least two physicians)
Patients with subjective symptoms of dyspnea that have worsened over the two weeks prior to registration
Patients who experience dyspnea at rest with an mBorg scale score of 3 or higher at the time of registration (initial eligibility assessment)
Patients who cannot maintain an arterial oxygen partial pressure (PaO2) of 60 Torr or more or an SpO2 of 90% or more on room air at rest
Patients who are 18 years of age or older at the time of consent acquisition
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An exploratory study to investigate the long-term tolerability of High-flow Nasal Cannula (HFNC) in patients who have completed a phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total duration of HFNC use over six days from the end of a phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients.
The duration of HFNC use is defined as the period from the start of observation until the criteria for discontinuing HFNC are met.
The discontinuation of HFNC in this study is defined as not using HFNC continuously for more than 12 hours.
Key secondary outcomes
Evaluate the changes in the mBorg Scale for dyspnea at rest over six days.
Assess the response rate.
Evaluate the desire to continue HFNC therapy.
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
Eligibility Criteria (The same as those of A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients, and evaluated simultaneously with the eligibility criteria for that trial, followed by patient registration)
Patients who meet all of the following criteria are eligible:
Patients who have received a pathological or clinical diagnosis of advanced cancer before registration
Patients with an ECOG PS of 3 or 4 (as determined by at least two physicians)
Patients with subjective symptoms of dyspnea that have worsened over the two weeks prior to registration
Patients who experience dyspnea at rest with an mBorg scale score of 3 or higher at the time of registration (initial eligibility assessment)
Patients who cannot maintain an arterial oxygen partial pressure (PaO2) of 60 Torr or more or an SpO2 of 90% or more on room air at rest
Patients who are 18 years of age or older at the time of consent acquisition
Additional Eligibility Criteria (These are additional eligibility criteria for this observational study and are evaluated at the end of A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients. Patients who met the initial eligibility criteria but do not meet the additional eligibility criteria at the time of evaluation can still be included in the observational study. If the additional eligibility criteria are not met, the six-day observation will not be conducted.)
Patients who have completed the 24-hour evaluation in A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients.
Patients who are scheduled to start or continue HFNC in routine clinical practice
Key exclusion criteria
Exclusion Criteria (The same as those of A phase III study of High-Flow Nasal Cannula for relieving dyspnea in advanced cancer patients, and evaluated simultaneously with the eligibility criteria for that trial)
1.Patients currently receiving mechanical ventilation, including NPPV, where the continuation of mechanical ventilation is deemed medically appropriate
2.Patients scheduled to receive mechanical ventilation, including NPPV
3.Patients using HFNC at the time of registration
4.Patients with impaired consciousness, cognitive dysfunction, or mental illness that prevents appropriate communication
5.Patients receiving continuous sedation
6.Patients using opioid rescue medication more than eight times a day
7.Patients participating in other clinical trials that could affect the evaluation and results of this study
8.Patients who started the following treatments within 28 days before registration or are scheduled to start these treatments during the trial period:
Surgical treatments, anticancer therapies, or chest radiotherapy for the primary disease that could improve dyspnea
9.Patients who started the following treatments within seven days before registration or are scheduled to start these treatments during the trial period:
Intravenous antibiotics for bacteremia or pneumonia that could improve dyspnea
10.Patients who started the following treatments within 24 hours before registration or are scheduled to start these treatments during the trial period:
Thoracentesis, drainage of the pleural cavity, or pericardiocentesis
11.Other cases deemed inappropriate for participation in this clinical study by the principal investigator or sub-investigator
Additional Exclusion Criteria
Patients with impaired consciousness, cognitive dysfunction, or mental illness at the start of the observational study that prevents appropriate communication for clinical study evaluation
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hagimoto |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
489-8642
Address
160, nishioiwake-cho, Seto, Aichi, Japan.
TEL
0561-82-5101
satoshi.hagimoto@gmail.comgmail.com
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | hagimoto |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
489-8642
Address
160, nishioiwake-cho, Seto, Aichi, Japan.
TEL
0561-82-5101
Homepage URL
lung@tosei.or.jp
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Department of Respiratory Medicine and Allergy
Address
160, nishioiwake-cho, Seto, Aichi, Japan.
Tel
0561825101
lung@tosei.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
和歌山県立医科大学附属病院(和歌山県)、神戸市立医療センター中央市民病院（兵庫県）、松江医療センター（島根県）、近畿中央呼吸器センター（大阪府）、東北大学病院（宮城県）、済生会宇都宮病院（栃木県）、藤田医科大学病院（愛知県）、名古屋医療センター（愛知県）、中京病院（愛知県）、大垣市民病院（愛知県）、松波総合病院（岐阜県）、公立那賀病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062805
