The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby improving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen. A…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of hair loss
Secondary outcome
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
Background summary
Alopecia is a common and distressing side effect of chemotherapy. Scalp cooling
is practiced in order to reduce hair loss in patients receiving chemotherapy.
In publicized articles about scalp cooling, methods and results vary
remarkably. However, in general, positive outcomes are reported. Scalp cooling
is well tolerated by most patients. Described side effects are generally
reversible and not serious.
Although scalp cooling has been practiced for many years, several essential
questions still have to be answered. For some chemotherapy regimens, effects of
scalp cooling have been proven, for other particular schemes minimal or no
information about the general outcome of scalp cooling is available.
Furthermore no research has been carried out to determine an optimal
post-infusion cooling time.
Study objective
The primary aim of current study is to assess the effect of different cooling
times on the efficacy of scalp cooling, thereby improving the results of scalp
cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC)
regimen.
A secondary aim is comparison of Quality Of Life (QOL) during chemotherapy in
cooled and non-cooled patients, which will provide information about the impact
of chemotherapy-induced hair loss.
Study design
The primary part of the research is a prospective randomized trial. Patients
will be randomly assigned to a post-infusion cooling time of 90 (standard) or
150 minutes. Non-cooled patients are controls for comparing hair loss and
quality of life during chemotherapy.
Intervention
Cooled patients are asked to complete a written questionnaire during each
chemotherapy cycle and fill in a computerized quality of life measurement
during cycle 2 and 5. Cooled patients will be randomized over 2 different
post-infusion cooling times. Non-cooled patients are asked to complete the
written questionnaire and the quality of life measurement during cycle 2 and 5.
Study burden and risks
The burden for patients is completing questionnaires. Cooled patients go
through additional burden as a result of randomization. Patients assigned to
the group with long post-infusion cooling times, will be present in the
hospital for 60 more minutes then patients with the standard post-infusion
cooling times.
There are no additional risks for participating patients.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
Intravenous administered FEC or FEC-D (docetaxel) regimen with an epirubicine dose of 90 mg/m2 or more at 3-weekly intervals, age 18 years or more, written informed consent
Exclusion criteria
boldness before the start of the study,hematological malignancies with generalized haematogenic metastases and if in those conditions chemotherapy is given with a curative intent, clinical signs of sclap metastases
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN97879847 |
| CCMO | NL12192.094.06 |