Condition category
Cancer
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.geefhaareenkans.info

Contact information

Type

Scientific

Primary contact

Ms Corina van den Hurk

ORCID ID

Contact details

Integraal Kankercentrum Zuid
Sector Onderzoek
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR680

Study information

Scientific title

Acronym

POSTFEC

Study hypothesis

20 to 30% improvement of scalp cooling results due to longer post-infusion cooling times.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Breast cancer, hair loss

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil, 4-epidoxorubicin, cyclophosphamide, epirubicin

Primary outcome measures

Amount of hair loss

Secondary outcome measures

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

Overall trial start date

01/06/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Intravenously administered FEC-regimen with an epirubicin dose of 90 mg/m^2 or more at three-weekly intervals
2. Aged 18 years or more
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

130

Participant exclusion criteria

1. Baldness 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 scalp metastases

Recruitment start date

01/06/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Integraal Kankercentrum Zuid
Eindhoven
5612 HZ
Netherlands

Sponsor information

Organisation

Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)

Sponsor details

P.O. Box 501
Alkmaar
1800 AM
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Comprehensive Cancer Centre, South Region (Integraal Kankercentrum Zuid)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Interzol

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mitialto Foundation (Stichting Mitialto)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for the Support of the Care of Cancer, South Region (Stichting Ondersteuning Regionale Kankerzorg Zuid)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes