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A study of scalp skin temperature during scalp cooling in patients treated with chemotherapy.

A study of scalp skin temperature during scalp cooling in patients treated with chemotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23651
Enrollment
12
Registered
2010-05-26
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scalp cooling, alopecia, temperature, FEC chemotherapy Hoofdhuidkoeling, haaruitval, temperatuur, FEC chemotherapie

Interventions

None listed

Sponsors

Medisch Centrum Alkmaar
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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).

Contacts

Public ContactM.M.C. Komen

Wilhelminalaan 12

manon.komen@mca.nl+31 (0)72 5482872

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)