A study to determine the effect of post-infusion cooling time in the high dose 5-fluorouracil, 4-epidoxorubicin and cyclophosphamide (FEC)-regime

ISRCTN ISRCTN97879847
DOI https://doi.org/10.1186/ISRCTN97879847
Protocol serial number NTR680
Sponsor Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
Funders Comprehensive Cancer Centre, South Region (Integraal Kankercentrum Zuid), Interzol, Mitialto Foundation (Stichting Mitialto), Foundation for the Support of the Care of Cancer, South Region (Stichting Ondersteuning Regionale Kankerzorg Zuid)
Submission date
21/07/2006
Registration date
21/07/2006
Last edited
04/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Corina van den Hurk
Scientific

Integraal Kankercentrum Zuid
Sector Onderzoek
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymPOSTFEC
Study objectives20 to 30% improvement of scalp cooling results due to longer post-infusion cooling times.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer, hair loss
InterventionRandomly assigned post-infusion cooling time of 90 or 150 minutes
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)5-fluorouracil, 4-epidoxorubicin, cyclophosphamide, epirubicin
Primary outcome measure(s)

Amount of hair loss

Key secondary outcome measure(s)

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

Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target sample size at registration130
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Integraal Kankercentrum Zuid
Eindhoven
5612 HZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Study website Study website 11/11/2025 11/11/2025 No Yes
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