UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Kazutaka Narui
Organization	Yokohama City University Medical Center
Division name	Department of Breast and Thyroid Surgery
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	Jumpei Tokumaru
Organization	Yokohama City University Medical Center
Division name	Pharmaceutical Department
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021461