The primary objective of this pilot study is to check the feasibility of the main study. The primary objective of the main study is to identify a cut-off score under which alopecia can be prevented by scalp cooling.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Little is known about the influence of temperature on the outcome of scalp
cooling. This pilot study will check the feasibility of the main study, after
which specific parameters/outcome will be defined. Hair loss will be measured
using the World Health Organisation (WHO) grading system for alopecia and
asking the patient whether or not a wig or shawl is required.
Secondary outcome
n.v.t.
Background summary
Alopecia is an almost inevitable side-effect of chemotherapy treatment. In
cancer patients chemotherapy-induced alopecia is experienced as one of the
side-effects with the most impact. Several factors may contribute to the
severety of hair loss, including dose, drug schedule, combinations with other
cytotoxic agents as well as hair care practices. Research shows scalp cooling
is often an effective method to prevent chemotherapy-induced hair loss. Data on
parameters that can affect the effect of scalp cooling are scarce. Scalp skin
temperature, scalp skin perfusion, liverfunction and scalp cooling time can
possibly contribute and have to be taken into account in improving the protocol
for scalp cooling during administration of chemotherapy.
Study objective
The primary objective of this pilot study is to check the feasibility of the
main study. The primary objective of the main study is to identify a cut-off
score under which alopecia can be prevented by scalp cooling.
Study design
This is a single-centre observational pilot study. The study will be conducted
in the outpatient chemotherapy clinic of the department of Internal Medicine of
the Medical Centre Alkmaar. Patients will be asked to participate in the study
at the time of their first contact with the oncology nurse to schedule their
first chemotherapy. After providing informed consent, they will be followed for
six consecutive outpatient visits.
Study burden and risks
The burden for patients is attaching the thermocouple to the skin using theatre
glue and completing questionnaires.
There are no additional risks for participating patients.
Wilhelminalaan 12
1815 JD Alkmaar
NL
Wilhelminalaan 12
1815 JD Alkmaar
NL
Listed location countries
Age
Inclusion criteria
Intravenous administered FEC-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 clinical signs of scalp 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 |
|---|---|
| CCMO | NL31325.094.10 |