Unique ID issued by UMIN | UMIN000025625 |
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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 |
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
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
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
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
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
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.
Others
Prospective observational study
Exploratory
Pragmatic
Not applicable
The time course of docetaxel-induced peripheral edema by subjective and objective outcome measures
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
Observational
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
1) Patients who have peripheral edema at the time of enrollment
2) Patients who considered inadequate for inclusion in this trial by the physician
80
1st name | |
Middle name | |
Last name | Masaya Hattori |
Aichi Cancer Center
Department of Breast Oncology
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
052-762-6111
mhattori@aichi-cc.jp
1st name | |
Middle name | |
Last name | Masaya Hattori |
Aichi Cancer Center
Department of Breast Oncology
1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
052-762-6111
mhattori@aichi-cc.jp
Department of Breast Oncology, Aichi Cancer Center
none
Self funding
NO
愛知県がんセンター中央病院(愛知県)
2017 | Year | 01 | Month | 11 | Day |
Partially published
The 25th Annual Meeting of the Japanese Breast Cancer Society
Completed
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 07 | Month | 01 | Day |
Prospective observational study
2017 | Year | 01 | Month | 11 | Day |
2018 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029471
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