No registrations found.
ID
Source
Brief title
Health condition
Scalp cooling, alopecia, temperature, FEC chemotherapy
Hoofdhuidkoeling, haaruitval, temperatuur, FEC chemotherapie
Sponsors and support
Foreest Medical School
Intervention
Outcome measures
Primary outcome
The pilot study will check the feasibility of the main study, after which specific parameters/outcomes will be defined. Hair loss will be measured asking the patient whether or not a wig or head cover is required, using the World Health Organisation (WHO) grading system and a visual analogue scale (VAS), making pictures and using the trichometer (a diagnostic instrument for measuring changes in hair quantity (mass), hair diameter, and hair density).
Secondary outcome
N/A
Background summary
The primary aim of this study is to assess variations in scalp skin temperature between patients during scalp cooling in the high dose FEC-regimen, thereby improving the results of scalp cooling in the high dose 5Fluorouracil-Epirubicin-Cyclophosphamide (FEC) regimen.
Study objective
Skin temperature can possibly affect the effect of scalp cooling. First a pilot study will be conducted to check the feasibility of the main study. The primary objective of the main study is to identify a cut-off score under which alopecia can be prevented by scalp cooling.
Study design
N/A
Intervention
N/A
Inclusion criteria
1. Patients with breast cancer;
2. Age 18 years or more;
3. Written informed consent;
4. Indication for three to six cycles of intravenous administered 5-Fluorouracil-Epirubicin-Cyclophosphamide (FEC) regimen with an epirubicine dose of 90 mg/m2 or more at 3-weekly intervals.
Exclusion criteria
1. Boldness before the start of the study;
2. Clinical signs of scalp metastases;
3. Cold sensitivity;
4. Cold agglutinin disease;
5. Cryoglobulinemia;
6. Cryofibrinogenemia;
7. Cold posttraumatic dystrophy.
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 | NL2214 |
| NTR-old | NTR2339 |
| Other | METC Noord-Holland : M010-010 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |