No registrations found.
ID
Source
Brief title
Health condition
breast cancer
FEC high chemotherapy
alopecia
scalp cooling
Sponsors and support
Medisch Centrum Almaar
s.m.de.bie@mca.nl
072-5484444
Intervention
Outcome measures
Primary outcome
The need to wear a wig or other head covering
Secondary outcome
1. Acceptability of scalp cooling;
2. Relation of the efficacy of scalp cooling with prior chemotherapy/radiotherapy or hormonal treatment, liver- or kidney function disorder and type of hair;
3. Quality Of Life during chemotherapy.
Background summary
The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby mproving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen.
Study objective
20 to 30% improvement of scalp cooling results due to longer post-infusion cooling times.
Intervention
Randomly assigned post-infusion cooling time of 90 or 150 minutes.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL621 |
| NTR-old | NTR680 |
| Other | : 2 |
| ISRCTN | ISRCTN97879847 |