The study on the efficacy and the safety of scalp cooling system to prevent hair loss in breat cancer patients receiving chemotherapy
- Conditions
- breast cancer
- Registration Number
- JPRN-UMIN000029984
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Not provided
1)Any skin diseases 2)alopecia 3)history of radiation for head 4)allergy for doxorubicin, docetaxel, or cyclophosphamide 5)allergy for silicone 6)Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 7)history of ischemic heart disease (angina pectoris or myocardial infarction) or cardiomyopathy 8)clinically significant infectious disease 9)history of interstitial pneumonia or pulmonary fibrosis 10)uncontrolled diabetes mellitus or under insulin treatment 11)the other malignant cancers 12)mental disease, or difficult-to-treat psychiatric patient 13)Raynaud's disease 14)Cold agglutinin disease 15)Cryoglobulinemia 16)Any other cases who are regarded as inadequate for study enrollment by the attending doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the proportion of patients which were able to complete 4 cycles of postoperative adjuvant AC or TC therapy in patients who used the scalp-cooling system
- Secondary Outcome Measures
Name Time Method the degrees of comfort, satisfaction, the efficacy of hair loss prevention, the rates of adverse events, and the rates of metastases in patients who used the scalp-cooling system