No registrations found.
ID
Source
Brief title
Health condition
Signaalpad, kaalheid, chemotherapie, hoofdhuidkoeling
Pathway, alopecia, chemotherapy, scalp cooling
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.
The objective of this study is to explore molecular damage-response pathways such as p53 expression in hair follicles
after chemotherapy.
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 objective
Damage response pathways can possibly explain the working mechanism of scalp cooling
Study design
Hair samples will be collected at different time points.
Hair samples will be collected at:
t=0 (before treatment with chemotherapy)
t=2 (two days after chemotherapy)
t=4 (four days after chemotherapy)
t=8 (eight days after chemotheray)
t=12 (twelve days after chemotherapy)
t=16 (sixteen days after chemotherapy)
The study will end when no fluctuation is seen between the different time-points.
Intervention
This pilot study will explore molecular damage-response pathways such as p53 expression in hair follicles after chemotherapy. It is known that all patients treated wit TAC, FEC and AC (any combination chemotherapy schedule including an anthracycline) lose their hair within two to three weeks. This pilot study explores various time-points to detect whether p53 fluctuates between these time-point. If there is no fluctuation between the different time-points in ten patients, it is unlikely to detect any fluctuation when more patients are included.
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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4192 |
NTR-old | NTR4343 |
CCMO | NL45436.094.13 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON40394 |