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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018544
Receipt No. R000021461
Scientific Title A prospective observational study for impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Date of disclosure of the study information 2015/08/05
Last modified on 2018/02/06

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Basic information
Public title A prospective observational study for
impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Acronym A prospective observational study for
impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Scientific Title A prospective observational study for
impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Scientific Title:Acronym A prospective observational study for
impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Region
Japan

Condition
Condition cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy.
Basic objectives2 Others
Basic objectives -Others To evaluate impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rate of no impact on patient's QOL during 0 to 120 hours (all phase) after an anticancer agent dosage start
Key secondary outcomes 1) Rate of no impact on patient's QOL during 0 to 24 hours (acute phase) after an anticancer agent dosage start
2) Rate of no impact on patient's QOL during 24 to 120 hours (delay phase) after an anticancer agent dosage start
3) Complete protection rate during 0 to 24 hours (acute phase) after an anticancer agent dosage start
4) Complete protection rate during 24 to 120 hours (delay 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 anticancer agent of high emetic risk
2) The patient whom an anticancer agent is not given to anticancer agent of high emetic risk in the past
3) The planned patient who gives antiemetic drugs including aprepitant or fosaprepitant and palonosetron
4) Age at the time registration is a patient 20 years or older
5) The patient who did not experience nausea and vomiting within 24 hours before giving an anticancer agent
6) Given written informed consent
Key exclusion criteria 1) Any other inadequacy for this study
2) Presence of brain metastases
3) Hypercalcemia
4) Gastrointestinal obstruction
5) other medication or participation in studies that might modify the usual chemotherapy induced nausea and vomiting pattern or the emetogenous level of the chemotherapy regimen received
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Narui
Organization Yokohama City University Medical Center
Division name Department of Breast and Thyroid Surgery
Zip code
Address 4-57 Urahunecho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email nr1@gc5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jumpei Tokumaru
Organization Yokohama City University Medical Center
Division name Pharmaceutical Department
Zip code
Address 4-57 Urahunecho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email toku_j@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

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
2015 Year 08 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 30 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information We evaluate impact on patient's quality of life associated risk factor of chemotherapy induced nausea and vomiting in highly emetogenous chemotherapy.

Management information
Registered date
2015 Year 08 Month 05 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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