Hair loss restraint by scalp cooling enforcement
Phase 2
Suspended
- Conditions
- Breast cancer
- Registration Number
- JPRN-jRCTs072180051
- Lead Sponsor
- TOKUNAGA Eriko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Female
- Target Recruitment
- 21
Inclusion Criteria
1)Histologically comfirmed primary breast cancer
2)Stage I, II or III
3)Female aged 20 to 75 years old
4)The case for that is planned anthracycline, taxan-based chemotherapy and in that hair loss is expected
5)No history of the chemotherapy for the malignant tumor
6)Signed informed consent of the patient for registration
Exclusion Criteria
1)Chilly allergy
2)Cold agglutinin disease
3)Any scalp skin tumor
4)History of radiation for head
5)Temporomandibular disorder or disease to a chin
6)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 Rate of grade 0 or 1 of hair loss, according to CTCAE ver4.0 classification
- Secondary Outcome Measures
Name Time Method Rate of hair loss restraint in each evaluation timing <br>Hair loss accompanying symptom <br>Hair loss period <br>Safety <br>Adverse events