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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025625

Enrollment

Registered

2017-01-11

Start date

2015-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The time course of docetaxel-induced peripheral edema by subjective and objective outcome measures	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMasaya Hattori

Aichi Cancer Center Department of Breast Oncology

mhattori@aichi-cc.jp052-762-6111

Outcome results