UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025625
Receipt number 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 15:02:02

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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 or person

Institute

Department of Breast Oncology, Aichi Cancer 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


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

Value
https://center6.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