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The effect of scalp cooling on alopecia during Myocet/cyclophosphamide chemotherapy.


- candidate number13223
- NTR NumberNTR3573
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-aug-2012
- Secondary IDsNL38226.015.11 CCMO
- Public TitleThe effect of scalp cooling on alopecia during Myocet/cyclophosphamide chemotherapy.
- Scientific TitleMuticentre study to investigate the efficacy of scalp cooling for the prevention of Myocet/cyclofosfamideinduced alopecia in patients with metastatic breast cancer. MyCap study.
- ACRONYMMyCap
- hypothesisAlopecia (frequency and severity) induced by Myocet and cyclophosphamide will not be different compared to conventional doxorubicine and cyclophosphamide.
- Healt Condition(s) or Problem(s) studiedChemotherapy-induced alopecia
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate15-nov-2012
- Target number of participants70
- InterventionsThose 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.
- Primary outcomeAllopecia measured by trichometry.
- Secondary outcomeSubjective severity of allopecia.
- TimepointsEvery 3 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
MSD
- PublicationsN/A
- Brief summaryAllopecia 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.
- Main changes (audit trail)
- RECORD10-aug-2012 - 11-dec-2013


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