Female patients with stage I/II primary breast cancer who were scheduled to undergo adjuvant/neoadjuvant chemotherapy
Conditions
Interventions
Scalp cooling by scalp cooling device is done 30 minutes pre-chemotherapy, duration of chemotherapy and more than 90 minutes post-chemotherapy.
No cooling
Sponsors
Century Medical,Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. New diagnosis of breast cancer stage 1-2 2. Female with Age >= 20 and age <= 70 3. Planning to undergo 4 cycles of adjuvant/neoadjuvant chemotherapy by following regimens: - AC (Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2) - EC (Epirubicin 100 mg/m2 with cyclophosphamide 600 mg/m2) - TC (Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2) - FEC (Epirubicin100 mg/m2 with 5-Fluroruacil 500 mg/m2 and cyclophosphamide 500 mg/m2) A dose dense schedule is not allowed. 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Stage 3 or higher breast cancer 2. Any other concurrent malignancy including hematological malignancies 3. Baseline alopecia (defined CTCAE v4.0 grade >= 1) 4. Subjects with cold agglutinin disease or cold urticaria 5. Subjects who are scheduled for bone marrow ablation chemotherapy 6. Personal history of migraines, cluster or tension headaches 7. Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal 8. Serum Albumin < 3.0 g/dL 9. Subjects with anemia (defined as a hemoglobin < 10 g/dL) 10. Abnormal TSH, AND: If high, abnormal free T4 defined as out of normal limits If low, abnormal free T4 or T3 defined as out of normal limits 11. Subjects who have diabetes with a Hgb A1c > 7% 12. Subjects who have lichen planus or lupus 13. Subjects who are underweight (defined as a BMI < 17.5) 14. Subjects who have had previous chemotherapy exposure 15.Subjects with difficulty of the proper cap fitting 16. Subjects with head injury or burn 17. Participation in any clinical trials at present or up to 30 days before consent acquisition. 18.Subjects with difficulty of complying with treatment regimen determined in the protocol 19.Life expectancy of subjects is expected less than 1 year. 20.Subjects determined to be ineligible by an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with no alopecia after the 4th cycle of chemotherapy treatment | — |
Countries
Japan
Contacts
Public ContactMegumi Okamoto
Century Medical,Inc. Clinical Affairs Group
Outcome results
None listed