A multicentre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss

Completed

• Conditions: Hair loss due to chemotherapy; Cancer; Cancer, hair loss

• Registration Number: ISRCTN00283877
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Intravenous administered docetaxel regimes
2. Age 18 years or more
3. Written informed consent

Exclusion Criteria

1. Boldness before the start of the study
2. Haematological malignancies with generalised haematogenic metastases (e.g. lymphoma, leukaemia and multiple myeloma) and if in those conditions chemotherapy is given with a curative intent
3. Clinical signs of scalp metastases
4. Cold sensitivity
5. Cold agglutinin disease
6. Cryoglobulinaemia
7. Cryofibrinogenaemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy and patient acceptability of scalp cooling.

Secondary Outcome Measures

Name	Time	Method
Relation of the efficacy of scalp cooling and:<br>1. Prior treatment with cytostatic agents<br>2. Prior or parallel hormonal treatment<br>3. Prior radiotherapy of the scalp<br>4. Liver metastases and/or liver or kidney function disorder<br>5. Type of hair (determined by race)