Alopecia (frequency and severity) induced by Myocet and cyclophosphamide will not be different compared to conventional doxorubicine and cyclophosphamide.
ID
Bron
Verkorte titel
Aandoening
chemotherapy-induced alopecia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Allopecia measured by trichometry.
Achtergrond van het onderzoek
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 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.
Patient population:
Female patients with metastatic breast cancer who will be treated with Myocet. 18 years and above.
Doel van het onderzoek
Alopecia (frequency and severity) induced by Myocet and cyclophosphamide will not be different compared to conventional doxorubicine and cyclophosphamide.
Onderzoeksopzet
Every 3 weeks.
Onderzoeksproduct en/of interventie
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.
Publiek
[default]
The Netherlands
Wetenschappelijk
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Female breast cancer patients, treated with Myocet and cyclophosphamide containing chemotherapy;
2. Life expectancy >=12 weeks;
3. ECOG performance scale 2;
4. Age 18 years and above.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allopecia prior to start of the study;
2. Simultaneously or shortly after study start: planned skull irradiation (if allopecia is expected);
3. Severely disturbed liver enzymes (see protocol for details);
4. Hair extensions.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3423 |
| NTR-old | NTR3573 |
| CCMO | NL38226.015.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35380 |