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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name