UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009855
Receipt No. 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 (Ver. 7)

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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
Email 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
Email breastc@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011546