UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010387 |
|---|---|
| Receipt number | R000012153 |
| Scientific Title | Study on the usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms caused by peripheral intravenous administration of oxaliplatin |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2013/04/01 17:19:35 |
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Basic information
Public title
Study on the usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms caused by peripheral intravenous administration of oxaliplatin
Acronym
usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms by of Oxaliplatin i.v
Scientific Title
Study on the usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms caused by peripheral intravenous administration of oxaliplatin
Scientific Title:Acronym
usefulness and safety of warmied infusions and local hot fomentations for vascular pain-like symptoms by of Oxaliplatin i.v
Region
| Japan |
Condition
Condition
Colorectal cancer patient
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates decrease of vascular pain-like symptoms of peripheral intravenous administration of oxaliplatin. The techniques to be used are the warming infusions with hot pack and the step-by-step local hot fomentations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
NRS:Numeric Rating Scale
Key secondary outcomes
enquetes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1st time chemotherapy
1. During heating is described in the report
2. If vascular pain happened, then the warming infusion is start.
3. NRS is performed for 5min, 10min, 15min. Subsequent check is performed every 15 minutes..
4. Patient's report is performed from day 1 to day 8.
Subsequently
1. Patients select one of the following before the start of infusion.
i) Warming infusion is performed from the time of the appearance of vascular pain.
ii) Performed prophylactically from the beginning.
Not select all.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Colorectal cancer patients treated with oxaliplatin by peripheral intravenous drip
2) Written patient consent was obtained from patients.
3) XELOX,XELOX+BV or SOX,SOX+BV
4) 20-79 years, gender does not matter
Key exclusion criteria
1)Patients with paresthesia or hemiplegia
2)Patient whose conscious level is not clear
3)Patients who are taking Celecoxib
Extension for vascular pain of the time of administration, increased lysates, mixed injection of dexamethasone
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Kato |
Organization
Yokohama city university hospital
Division name
Outpatient chemotherapy room
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Kato |
Organization
Yokohama city university hospital
Division name
Outpatient chemotherapy room
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama city university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 01 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012153
