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A study to determine the effect of post-infusion cooling time in the high dose FEC-regimen.

Completed
Conditions
breast cancerFEC high chemotherapyalopeciascalp cooling
Registration Number
NL-OMON25604
Lead Sponsor
S. de BieMedisch Centrum Almaars.m.de.bie@mca.nl072-5484444
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
130
Inclusion Criteria

1. Intravenous administered FEC-regimen with an epirubicine dose of 90 mg/m2 or more at 3-weekly intervals;
2. Age 18 years or more;
3. Written informed consent.

Exclusion Criteria

1. Boldness 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 sclap metastases.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The need to wear a wig or other head covering
Secondary Outcome Measures
NameTimeMethod
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.
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