None listed
Conditions
Brief summary
The primary purpose of this study is to gather more scientific data on the efficacy of scalp cooling to prevent chemotherapy-induced hair loss and to assess the effect of specific temperature used on the efficacy of scalp cooling. Who is it for? You may be eligible to join this study if you are 18 or over and have histologically confirmed invasive breast cancer, and a planned course of one of the approved chemotherapy regimens. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive scalp-cooling at 3 degrees Celsius or 5 degrees Celsius. Scalp-cooling involves wearing a cap connected to a cooling device that will lower the temperature of your scalp. The cap is to be worn at each chemotherapy treatment 30 minutes before, during and 90 minutes after the chemotherapy treatment. Patient outcomes will then be assessed through patient-reported level of hair loss at the end of planned chemotherapy and monitoring of short-term and long-term side effects of scalp-cooling for 10 years after the end of planned chemotherapy. It is hoped that the findings of this trial will enhance our knowledge of the efficacy and long-term safety of using scalp-cooling to prevent chemotherapy-induced alopecia in breast cancer patients.
Interventions
scalp-cooling treatment:patient wears a cap which is connected to a refrigerated cooling system which pumps liquid coolant through the cap to keep the scalp cool and blood vessels constricted to minimise chemotherapy delivery to hair follicles. The TGA-approved cap will be fitted to patients on day 1 of each chemotherapy cycle at one of two temperature settings (3 degrees vs 5 degrees Celsius) 30 min prior, during and 90min after their chemotherapy treatment for the duration of their planned chemotherapy. Scalp cooling start/stop time, chemotherapy start/stop time as well as duration of scalp cooling interruption, if applicable, will be recorded.
Sponsors
Study design
Eligibility
Inclusion criteria
- histologically confirmed invasive breast cancer - suitable to receive one of the approved chemotherapy regiments, defined in the protocol, in the neo/adjuvant or metastatic setting - minimum understanding of English language to complete quality of life questionnaire - willingness to be followed for 10 years
Exclusion criteria
- history of malignant primary brain tumour - history of scalp or brain metastasis - recommended chemotherapy given on weekly schedule - patient suffering from cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrogenemia or cold traumatic dystrophy - prior chemotherapy for any reason - allergy to silicon - concurrent treatment affecting hair growth