UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052208 |
|---|---|
| Receipt number | R000059566 |
| Scientific Title | Prospective observational study on prevention methods and causes of vasculitis and vascular pain caused by vinorelbine |
| Date of disclosure of the study information | 2023/09/18 |
| Last modified on | 2024/09/20 18:03:34 |
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Basic information
Public title
Prospective observational study on prevention methods and causes of vasculitis and vascular pain caused by vinorelbine
Acronym
Prospective observational study on prevention methods and causes of vasculitis and vascular pain caused by vinorelbine
Scientific Title
Prospective observational study on prevention methods and causes of vasculitis and vascular pain caused by vinorelbine
Scientific Title:Acronym
Prospective observational study on prevention methods and causes of vasculitis and vascular pain caused by vinorelbine
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study focused on patients who underwent surgery for lung cancer and were scheduled to receive cisplatin and vinorelbine (VNR) combination therapy as adjuvant chemotherapy. Historically, we evaluated the preventive effect of vascular pain and vasculitis by administering physiological saline at the same time as VNR, using the incidence of vasculitis and vascular pain due to VNR as a control, compared to a group in which no physiological saline was administered. The purpose is to investigate this in a cohort study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Frequency, severity, and range of vascular pain and vasculitis after administration of vinorelbine
Key secondary outcomes
Electrolyte abnormalities, appearance of edema, incidence of heart failure, and BNP at the end of the treatment period
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
:Prospective observation group:
1) Patients undergoing postoperative chemotherapy using a combination of cisplatin and vinorelbine after lung cancer surgery
2) Patients who can consent to conduct this study
3) Patients who can express their own will to consent to this study
Retrospective observation group:
1) Patients who received postoperative chemotherapy using a combination of cisplatin and vinorelbine after lung cancer surgery
person
Key exclusion criteria
Exclusion criteria: Prospective observation group:
1) Used for treatments other than cisplatin + vinorelbine combination therapy for lung cancer
Patients on regimens containing vinorelbine
2) Patients with heart failure
3) Patients with poor renal function
Retrospective observation group:
1) Used for treatments other than cisplatin + vinorelbine combination therapy for lung cancer
Patients on regimens containing vinorelbine
2) Patients with a history of heart failure
3) Patients with poor renal function
4) This treatment is performed on the 1st day and the 8th day, but patients who complete the treatment without performing the treatment on the 8th day
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | ISHII |
Organization
Showa University School of Pharmacy
Division name
Department of Hospital Pharmaceutics
Zip code
142-8555
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
shun.pharm@cmed.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | ISHII |
Organization
Showa University School of Pharmacy
Division name
Department of Hospital Pharmaceutics
Zip code
142-8555
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
TEL
03-3784-8000
Homepage URL
shun.pharm@cmed.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Showa University Research Ethics Review Board
Address
1-5-8, Shinagawa-ku, Tokyo, 142-8555, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.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
| 2023 | Year | 09 | Month | 18 | 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
7
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In the treatment of lung cancer, surgical resection is targeted at patients who later wish to undergo combination therapy with CDDP and VNR.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before the start of the examination
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059566
