Operable breast cancer
Conditions
Interventions
Each patients wears frozen globes and elastic stockings on the dominant hand and foot
no treatment
Sponsors
The Supporting Center for Clinical Research and Education
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients are histologically proven breast cancer (2) Aged 20-70 (3) Scheduled to receive nab-paclitaxel following other chemotherapy (4) No prior chemotherapy for breast cancer (5) Performance Status (PS) 0-1 (6) Patients are judged by investigators with adequate organ function within two weeks neutrophil counts >= 1,500/mm3 platelets >= 10.0*10^4/mm3 hemoglobin >= 10.0g/dL AST < 100U/L ALT < 100U/L T-Bil <= 1.5mg/dL Creatinine < 1.5mg/dL (7) Without history or complication of peripheral neuropathy (8) With written informed consent
Exclusion criteria
Exclusion criteria: (1) With allergy for material of frozen globe and elastic stocking (2) Using elastic stocking regularly (3) With server artery dysfunction and congestive heart failure, just after dermal graft, necrosis, sever edema, suppurative disease on the skin (4) With extreme leg deformity (5) Administering medicine for thrombosis (6) Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and timing of grade 2 or higher peripheral neuropathy during nab-paclitaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)The incidence of grade 2 or higher peripheral neuropathy at the end of nab-paclitaxel (2)HRQOL (3)The incidence of peripheral neuropathy at five year after nab-paclitaxel administration (4)Safety | — |
Countries
Japan
Contacts
Public ContactNorikazu Masuda
Osaka National Hospital Department of Surgery
Outcome results
None listed