UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010165
Receipt number R000011903
Scientific Title A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Date of disclosure of the study information 2013/03/05
Last modified on 2013/03/05 14:03:23

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Basic information

Public title

A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.

Acronym

A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.

Scientific Title

A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.

Scientific Title:Acronym

A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We search for a risk factor of chemotherapy induced nausea and vomiting in the colorectal cancer patient who performed standard antiemetic therapy.

Basic objectives2

Others

Basic objectives -Others

To search for a risk factor of chemotherapy induced nausea and vomiting in the colorectal cancer patient who performed standard antiemetic therapy.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Complete response rate during 24 to 120 hours (delay phase) after an anticancer agent dosage start

Key secondary outcomes

1. Complete response rate during 0 to 24 hours (acute phase) and 0 to 120 hours (all phase ) after an anticancer agent dosage start
2. Complete control rate during acute phase and delay phase and all phase after an anticancer agent dosage start
3. Grade of nausea during acute phase and delay phase and all phase after an anticancer agent dosage start


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

1. The patient who plans the medication of the following anticancer agents as colorectal cancer chemotherapy
CPT-11 or oxaliplatin
2. The patient whom an anticancer agent is not given to or an anticancer agent of low emetic risk has been given to in the past
3. The planned patient who gives the following antiemetic drugs in the time giving an anticancer agent
day 1 palonosetron (0.75mg) i.v.
dexamethasone (9.9mg) i.v.
day 2, 3 dexamethasone (8mg) p.o.
4. Age at the time of the registration is a patient 20 years or older
5. The patient who can fill in a diary with a symptom exactly
6. Given written informed consent

Key exclusion criteria

1. The patient who experienced nausea or vomiting within 24 hours before giving an anticancer agent
2. Any other inadequacy for this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Itaru Endo

Organization

Yokohama city university graduate school of medicine

Division name

Department of gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuki Watanabe

Organization

Yokohama City University Hospital

Division name

Department of gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL


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

横浜市立大学附属病院
横浜市立大学附属市民総合医療センター
国立病院横浜医療センター
横浜市立市民病院
藤沢市民病院
横須賀共済病院
横須賀市立市民病院
横浜市立みなと赤十字病院
済生会横浜市南部病院
済生会若草病院
横浜船員保険病院
横浜掖済会病院
長津田厚生総合病院
NTT東日本関東病院
市立伊東市民病院


Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 05 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

Open public recruiting

Date of protocol fixation

2013 Year 02 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2013 Year 03 Month 05 Day

Last modified on

2013 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011903


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name