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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25604

Enrollment

130

Registered

2006-05-11

Start date

2007-03-26

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

breast cancer FEC high chemotherapy alopecia scalp cooling

Interventions

Randomly assigned post-infusion cooling time of 90 or 150 minutes.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The need to wear a wig or other head covering	—

Secondary

Measure	Time frame
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.	—

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)