PrimaryTo assess the efficacy of scalp cooling in preventing allopecia due to Myocet chemotherapy by the objective method of trichometry. Secondary:* Assess the efficacy of scalp cooling by comparing the objective method (trichometry) with the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
haaruitval t.g.v. chemotherapie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Allopecia measured by trichometry.
Secondary outcome
Subjective severity of allopecia.
Background summary
Allopecia due to chemotherapy is for women with breast cancer one of the most
burdenful adverse effects of the cancer treatment. The psycological inpact is
considerable. Scalp cooling may be performed to reduce allopecia due to
chemotherapy. In general scalp cooling results in a satisfactory result in 50%
of cases. The efficacy of scalp cooling during chemotherapy with Myocet, de
liposomal variant of doxorubicin, and cyclophosphamide has never been
investigated. If effecive, this may result in a better quality of life.
Study objective
Primary
To assess the efficacy of scalp cooling in preventing allopecia due to Myocet
chemotherapy by the objective method of trichometry.
Secondary:
* Assess the efficacy of scalp cooling by comparing the objective method
(trichometry) with the subjective methods WHO score questionnaire and VAS
rating.
* Assess th efficacy of scalp cooling by comparing the trichometry results with
the use of a wig or comparable.
Study design
Open, non-randomized parallel group phase IV pilot study.
After the decision to treat a patient for medical reasons with Myocet, the
study and the option of scalp cooling will be discussed.
Those patients who choose to particpate and to perform scalp cooling, will be
allocated to the experimental group (chemotherapy plus scalp cooling plus
trichometry).
Those patients who choose to particpate and not to perform scalp cooling, will
be allocated to the control group (chemotherapy plus trichometry).
Normally 6 courses of Myocet will be adminsitered. Scalp cooling will be
performed during all cycles.
80 patients in total (40 in both groups), approx. 70 in NL.
Intervention
Treatment with or without scalp cooling. Trichometry.
Study burden and risks
Risk: In studies the generally good tolerabilty of scalp cooling had been
shown. During the 1st 10 minutes scalp cooling is normally perceived as cold
and sometimes unpleasant. Headache may occur, seldom severe and with a positive
effect of pain killers.
In theory it is possible that small, not visible metastases on the scalp may
be less accessible for chemotherapy due to the scalp cooling. Scal cooling is
applied for 30 years now. The results of investigations in several thousands of
patients have been reported. An increased frequency of metastases on the scalp
or elsewere has not been reported. A less favorable course of the disease after
scalp cooling has not been reported either.
Burden: Scalp cooling during every Myocet cycle. Extra visit duration per
cycle: approx. 2h, incl. trichometry and completion of questionnaire re.
allopecia and VAS rating.
p/a Dr. M.R. Nijziel, medisch oncoloog, Máxima MC, Postbus 90052
5600 MB Eindhoven
NL
p/a Dr. M.R. Nijziel, medisch oncoloog, Máxima MC, Postbus 90052
5600 MB Eindhoven
NL
Listed location countries
Age
Inclusion criteria
* Female breast cancer patients, treated with Myocet and cyclophosphamide containing chemotherapy.
* Life expectancy * 12 weeks.
* ECOG performance scale * 2.
* Age 18 years and above.
Exclusion criteria
* Allopecia prior to start of the study.
* Simultaneously or shortly after study start: planned skull irradiation (if allopecia is expected).
* Severely disturbed liver enzymes (see protocol for details).
* Hair extensions
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 |
|---|---|
| Other | Nederlandse Trial Register, registratienummer n.n.b. |
| CCMO | NL38226.015.11 |
| OMON | NL-OMON23571 |