UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009855 |
|---|---|
| Receipt number | R000011546 |
| Scientific Title | A prospective study of management of chemotherapy induced adverse event for breast cancer. |
| Date of disclosure of the study information | 2013/01/24 |
| Last modified on | 2020/04/22 12:27:50 |
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Basic information
Public title
A prospective study of management of chemotherapy induced adverse event for breast cancer.
Acronym
Management of chemotherapy induced adverse event
Scientific Title
A prospective study of management of chemotherapy induced adverse event for breast cancer.
Scientific Title:Acronym
Management of chemotherapy induced adverse event
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigation of chemotherapy induced adverse event for breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of >= Grade 3 adverse event
Key secondary outcomes
QOL
Proportion of all Grade adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Management of these chemotherapy induced adverse event.
1. Neurotoxicity
Taxane
2. Nausea and Vomitting
Anthracyclin
3. Skin disorder
Taxane
Lapatinib
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
Female
Key inclusion criteria
Inclusion Criteria
1) Histologically confirmed invasive breast cancer by biopsy and treatment of Taxanes/Anthracyclin/Lapatinib.
2) >=20years old
3) Written informed consent
Key exclusion criteria
Exclusion Criteria
1) Hypersensitivity of protocol therapy
2) Uncontrolled infection, diarrhea, bowel obstruction, diabetes, myocardinal infarction, heart failure, pulmonary fibrosis, pneumonitis, cerebrovascular disorder, other.
3) Active brain metastasis
4) Mental disorder
5) Severe myelosupression, renal and hepatic disfunction.
6) ascetic and pleural fluid
7) Pregnant, lactating or declined contraception
8) Patients considered ineligible by the attending physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Nakamura |
Organization
Showa University
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-8000
breastc@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Okuyama |
Organization
Showa University
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL
03-3784-8000
Homepage URL
breastc@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Bio-Ethical Committee,Showa University
Address
1-5-8, hatanodai, shinagawaku, Tokyo, japan
Tel
03-3784-8022
gakuji@ofc.showa-u.ac.jp
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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011546
Publication of results
Published
Result
URL related to results and publications
https://www.eurjbreasthealth.com/en/search-15?Authors=Hiromi%E3%80%80Okuyama
Number of participants that the trial has enrolled
36
Results
Adverse events : No grade 3-4 myalgia, or peripheral sensory neuropathy was observed in either group.
QoL : The time course of the mean QoL scores assessed using FACT-B, FACT-B TOI, and FACT-G.
HRQoL were similar in both groups, with no significant differences.
Results date posted
| 2020 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 08 | Month | 13 | Day |
Baseline Characteristics
Thirty-six eligible patients were enrolled in this study between March 2012 and March 2014. The baseline characteristics were well
balanced between the two groups.
Participant flow
This study was conducted to evaluate adverse events and HRQoL, as an add-on to a multicentre phase II trial of neoadjuvant nab-PTX compared with DTX in patients with early-stage breast cancer.
Adverse events
The most common grade 3-4 adverse event was neutropenia, which occurred in 44% and 33% of patients in the DTX and nab-PTX groups, respectively.There were no significant differences in haematological adverse events between the groups. Grade 1-2 non-haematological adverse events included myalgia (DTX 44%, nab-PTX 39%), arthralgia (DTX 33%, nabPTX 33%), and peripheral sensory neuropathy (DTX 56%, nab-PTX83%). No grade 3-4 myalgia,arthralgia, or peripheral sensory neuropathy was observed in either group.
Outcome measures
The primary endpoint was the occurrence of grade 3 or 4 adverseevents, and the secondary endpoints were QoL and adverse events of all grades.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011546
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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