The objective of this study is to explore molecular damage-response pathways such as p53 expression in hair follicles after chemotherapy.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Expression of damage-response pathways
Secondary outcome
NA
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 de most impact. Several factors may contribute to the severity of
hair loss including dose, drug schedule, combinations with other cytotoxic
agents as well as hair care practices. Research shows scalp cooling is an
effective method to prevent chemotherapy induced hair loss. The exact working
mechanism is unclear. Therefore we do not know why scalp cooling is effective
in one patient but not in another.
Study objective
The objective of this study is to explore molecular damage-response pathways
such as p53 expression in hair follicles after chemotherapy.
Study design
This is a multi-center observational study. The study will be conducted in the
outpatient chemotherapy clinic of the department of internal medicine of the
Medical Center Alkmaar. Patients will be asked to participate at the time of
their first contact with the oncology nurse to schedule their first
chemotherapy. After providing informed consent, hairs will be collected during
the first chemotherapy course.
Study burden and risks
The burden for patients consists of collecting hairs.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
- Female patients with breast cancer
- Age 18 years or more
- Written informed consent
- Indication for at leaust one cycle of intravenous administered Docetaxel-Adriamycin-Cyclofosfamide (TAC), Fluorouracil-Epirubicin-Cyclophosphamide (FEC) or Adriamycin-Cyclophosphamide (AC).
Exclusion criteria
- Use of scalp cooling
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL45436.094.13 |
OMON | NL-OMON22244 |