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 |
| Secondary identifying numbers | NTR680 |
- 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
Scientific
Integraal Kankercentrum Zuid
Sector Onderzoek
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | POSTFEC |
| Study objectives | 20 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) studied | Breast cancer, hair loss |
| Intervention | Randomly assigned post-infusion cooling time of 90 or 150 minutes |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil, 4-epidoxorubicin, cyclophosphamide, epirubicin |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 130 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Integraal Kankercentrum Zuid
Eindhoven
5612 HZ
Netherlands
5612 HZ
Netherlands
Sponsor information
Medical Centre Alkmaar (Medisch Centrum Alkmaar) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 501
Alkmaar
1800 AM
Netherlands
"ROR" |
https://ror.org/04vccmr34 |
|---|
Funders
Funder type
Hospital/treatment centre
Comprehensive Cancer Centre, South Region (Integraal Kankercentrum Zuid)
No information available
Interzol
No information available
Mitialto Foundation (Stichting Mitialto)
No information available
Foundation for the Support of the Care of Cancer, South Region (Stichting Ondersteuning Regionale Kankerzorg Zuid)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
