UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018544 |
|---|---|
| Receipt number | 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 10:57:09 |
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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
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
toku_j@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021461
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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