A study to determine the effect of post-infusion cooling time in the high dose 5-fluorouracil, 4-epidoxorubicin and cyclophosphamide (FEC)-regime
Completed
- Conditions
- CancerBreast cancer, hair loss
- Registration Number
- ISRCTN97879847
- Lead Sponsor
- Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 130
Inclusion Criteria
1. Intravenously administered FEC-regimen with an epirubicin dose of 90 mg/m^2 or more at three-weekly intervals
2. Aged 18 years or more
3. Written informed consent
Exclusion Criteria
1. Baldness before the start of the study
2. Hematological malignancies with generalized haematogenic metastases and if in those conditions chemotherapy is given with a curative intent
3. Clinical signs of scalp metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of hair loss
- Secondary Outcome Measures
Name Time Method 1. Acceptability of scalp cooling<br>2. Relation of the efficacy of scalp cooling with prior chemotherapy, radiotherapy or hormonal treatment, liver or kidney function disorder and type of hair<br>3. Quality of life during chemotherapy