UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017262 |
|---|---|
| Receipt number | R000020018 |
| Scientific Title | The effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis: a randomized, double-blind, placebo control, parallel group study. |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2017/04/26 18:22:21 |
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Basic information
Public title
The effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis: a randomized, double-blind, placebo control, parallel group study.
Acronym
The effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis.
Scientific Title
The effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis: a randomized, double-blind, placebo control, parallel group study.
Scientific Title:Acronym
The effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis.
Region
| Japan |
Condition
Condition
Phlebitis from 5FU+ cisplatin therapy
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of topical steroid to prevent 5FU+ cisplatin induced phlebitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Length of the pigmentation of the first day of the second cycle of chemotherapy
Key secondary outcomes
Length of the induration
Occurrence of the phlebitis
The number of days of developing phlebitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Twice a day (morning and evening) of topical steroid during FP therapy (4 or 5days).
Interventions/Control_2
Twice a day (morning and evening) of placebo ointment (Vaseline) during FP therapy (4 or 5days).
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
all the following conditions
(1)a candidate for FP therapy more than once
(2)planed to be obtain peripheral vascular access for chemotherapy
(3)Signed informed consent for this study
Key exclusion criteria
(1)Difficult to accept the researcher by mental disorder, cognitive impairment or physical disability
(2)using topical steroid on upper arm(e.g.dermatitis treatments)
(3)Inappropriate for this study in physician judgement
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Muto |
Organization
Kyoto university hospital
Division name
Department of Clinical oncology
Zip code
Address
54, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Hamabe |
Organization
Kyoto university hospital
Division name
Nursing depertment
Zip code
Address
54, Syogoinkawaharacho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-366-7500
Homepage URL
yhamabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Target Therapy Oncology
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
Address
Tel
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 26 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/04/26 | 170420解析手順.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/04/26 | ステロイド（京大）UMIN登録用全データ（試薬番号順）.xlsx |
