Unique ID issued by UMIN | UMIN000009855 |
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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 |
A prospective study of management of chemotherapy induced adverse event for breast cancer.
Management of chemotherapy induced adverse event
A prospective study of management of chemotherapy induced adverse event for breast cancer.
Management of chemotherapy induced adverse event
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
To investigation of chemotherapy induced adverse event for breast cancer.
Safety,Efficacy
Exploratory
Not applicable
Proportion of >= Grade 3 adverse event
QOL
Proportion of all Grade adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Management of these chemotherapy induced adverse event.
1. Neurotoxicity
Taxane
2. Nausea and Vomitting
Anthracyclin
3. Skin disorder
Taxane
Lapatinib
20 | years-old | <= |
Not applicable |
Female
Inclusion Criteria
1) Histologically confirmed invasive breast cancer by biopsy and treatment of Taxanes/Anthracyclin/Lapatinib.
2) >=20years old
3) Written informed consent
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
60
1st name | Seigo |
Middle name | |
Last name | Nakamura |
Showa University
Department of Breast Surgical Oncology
142-8666
1-5-8, hatanodai, shinagawaku, Tokyo, japan
03-3784-8000
breastc@med.showa-u.ac.jp
1st name | Hiromi |
Middle name | |
Last name | Okuyama |
Showa University
Department of Breast Surgical Oncology
142-8666
1-5-8, hatanodai, shinagawaku, Tokyo, japan
03-3784-8000
breastc@med.showa-u.ac.jp
Showa University
nothing
Self funding
Bio-Ethical Committee,Showa University
1-5-8, hatanodai, shinagawaku, Tokyo, japan
03-3784-8022
gakuji@ofc.showa-u.ac.jp
NO
昭和大学病院(東京都)
2013 | Year | 01 | Month | 24 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011546
Published
https://www.eurjbreasthealth.com/en/search-15?Authors=Hiromi%E3%80%80Okuyama
36
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.
2020 | Year | 04 | Month | 22 | Day |
2018 | Year | 08 | Month | 13 | Day |
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.
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.
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.
The primary endpoint was the occurrence of grade 3 or 4 adverseevents, and the secondary endpoints were QoL and adverse events of all grades.
Main results already published
2012 | Year | 08 | Month | 31 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2013 | Year | 01 | Month | 24 | Day |
2020 | Year | 04 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011546
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