Mechanisms of Scalp Cooling During Chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26586

Enrollment

Registered

2011-09-01

Start date

2011-05-01

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

Temperature, Scalp Cooling, Alopecia, Chemotherapy

Interventions

None listed

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 90-100 mg/m2 at 3-weekly intervals or Adriamycin-Cyclophosphamide (AC) (adryamycin at a dose of 60 mg/m2; 5. Subsequent chemotherapy consisting of decetaxel or paclitaxel is allowed after three cycles of FEC or AC.

Exclusion criteria

Exclusion criteria: 1. Clinical signs of scalp metastases; 2. Cold sensitivity; 3. Cold agglutinin disease; 4. Cryoglobulinemia; 5. Cryofibrinogenemia; 6. Cold posttraumatic dystrophy.

Design outcomes

Primary

Measure	Time frame
Hair loss will be the primary outcome variable. 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 a 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