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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025625
Receipt No. R000029471
Scientific Title Subjective and objective assessment of the peripheral edema in breast cancer patients who receive docetaxel-containing regimens in the adjuvant and neoadjuvant settings: a prospective observational study
Date of disclosure of the study information 2017/01/11
Last modified on 2018/01/11

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Basic information
Public title Subjective and objective assessment of the peripheral edema in breast cancer patients who receive docetaxel-containing regimens in the adjuvant and neoadjuvant settings: a prospective observational study
Acronym Subjective and objective assessment of the peripheral edema in breast cancer patients who receive docetaxel-containing regimens in the adjuvant and neoadjuvant settings: a prospective observational study
Scientific Title Subjective and objective assessment of the peripheral edema in breast cancer patients who receive docetaxel-containing regimens in the adjuvant and neoadjuvant settings: a prospective observational study
Scientific Title:Acronym Subjective and objective assessment of the peripheral edema in breast cancer patients who receive docetaxel-containing regimens in the adjuvant and neoadjuvant settings: a prospective observational study
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the incidence, time course and severity of docetaxel-induced peripheral edema by using both subjective and objective assessment methods among breast cancer patients receiving 4 cycles of docetaxel every 3 weeks as neoadjuvant or adjuvant therapy.
Basic objectives2 Others
Basic objectives -Others Prospective observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The time course of docetaxel-induced peripheral edema by subjective and objective outcome measures
Key secondary outcomes 1) The incidence and severity of docetaxel-induced peripheral edema by using both subjective and objective outcome measures
2) QOL(FACT-taxane) in patients receiving docetaxel-containing chemotherapy
3) Risk factors of docetaxel-induced peripheral edema
4) Correlation between subjective and objective evaluation of docetaxel-induced peripheral edema

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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who receive docetaxel-containing chemotherapy (Anthracycline followed by docdtaxel, Anthracycline followed by docdtaxel and trastuzumab, TC) as neoadjuvant or adjuvant chemotherapy
2) Patients who can be dosed initially at docetaxel 75 mg/m2
3) Eastern Cooperative Oncology Group performance status of 0,1 or 2
4) Patients who have adequate organ function, as determined by the following laboratory results, within 28 days before enrollment
Hemoglobin >= 9.0mg/dL
Serum creatinine value <= 1.5mg/dL
Left Ventricular Ejection Fraction (LVEF) >= 55% at baseline
5) Patients who provided written informed consent
Key exclusion criteria 1) Patients who have peripheral edema at the time of enrollment
2) Patients who considered inadequate for inclusion in this trial by the physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Hattori
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL 052-762-6111
Email mhattori@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Hattori
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL 052-762-6111
Homepage URL
Email mhattori@aichi-cc.jp

Sponsor
Institute Department of Breast Oncology, Aichi Cancer 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 25th Annual Meeting of the Japanese Breast Cancer Society
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 Completed
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2017 Year 01 Month 11 Day
Last modified on
2018 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029471

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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