Breast cancer
Conditions
Interventions
1.Scalp cooling using the Paxman Scalp Cooling Device was done 30 minutes prior to, during and 90 minutes after each chemo therapy infusion. 2.Patients are instructed to perform gentler hair care tha
Sponsors
Aichi Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.ECOG performance status 0 or 1 2.Adequate bone marrow,heart,liver and renal function 3.Informed consent is obtainable from the subject herself in documented form using the Consent Form
Exclusion criteria
Exclusion criteria: 1.Previous chemotherapy treatment 2.Already have alopecia >grade 1 by CTCAE v4.0 3.History of migraine headaches, hypothyroidism, uncontrolled diabetes, and anorexia. 4.Any condition for contraindication of chemotherapy 5.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 6.Difficulty to participate in this study due to mental illness or psychiatric symptoms 7.Any other reasons recognized as inadequate to participate in this study by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade0 [no hair loss] or grade 1 [<50% hair loss not requiring a wig]were considered to have hair preservation) at the end of 4 cycles of chemotherapy(TC or weekly PTX) by the physician in charge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Wig or head cap use 2.Differences in success rates according to chemotherapy regimen 3.Safety assessment: Adverse events related to device use 4.Safety assessment: Head skin metastasis at 5 years later | — |
Countries
Japan
Contacts
Public ContactHaruru Kotani
Aichi Cancer Center Department of Breast Oncology
Outcome results
None listed