Researchers from the Lester and Sue Smith Breast Center at Baylor College of Medicine are recruiting newly diagnosed breast cancer patients to participate in a new clinical trial testing the safety and efficacy of an investigational scalp cooling device to prevent hair loss associated with chemotherapy.
Other countries, such as Europe, Asia, Canada and Australia, have commonly used these types of devices, and they produced promising data. However, they have not been approved for use in the United States.
Dr. Julie Nangia, assistant professor in the Lester and Sue Smith Breast Center, and her colleagues will lead a multi-institutional clinical trial using a U.S. Food and Drug Administration Investigational Device Exemption to provide more data on one particular scalp cooling device’s safety and ability to prevent hair loss.
Nangia and her team will use the Paxman Hair Loss Prevention System as part of the trial. The system is a free-standing, electrically-powered, mobile refrigeration unit that circulates a refrigerated liquid coolant through a cooling cap that is attached to and covers the top of the patient’s head.
Chemotherapy attacks rapidly growing cancer cells but also attacks other rapidly growing cells in your body, such as those in your hair roots. Scalp cooling lowers the temperature of the head and scalp immediately before, after and during the administration of chemotherapy, which reduces the blood flow to hair follicles and prevents or minimizes damages to the hair roots.
“Hair loss is one of the most feared side effects of cancer chemotherapy, and a convenient method to minimize it would significantly improve quality of life,” said Dr. Kent Osborne, director of the Smith Breast Center and NCI-designated Dan L. Duncan Cancer Center. “This is an important trial in moving this particular method forward by informing us which chemotherapy and which patients benefit from this approach.
Participants interested in enrolling in the study must:
--Have a new diagnosis of breast cancer stage 1 or 2 and under the age of 70
--Plan to undergo neoadjuvant or adjuvant chemotherapy with curative intent
--Chemotherapy must be planned for at least four cycles of full-dose anthracycline or taxane based chemotherapy regimen, defined as one of the following chemotherapy regimens:
*Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 *Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 *Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent *Docetaxel 100mg/m2 as a single agent *Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 *Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
For more information or to enroll, please call Afife Batarse at (713) 798-1911.
Study participants will be followed until 2-4 weeks after completion of chemotherapy when the final alopecia (hair loss) assessment will occur and the questionnaires will be administered.
Participants will be followed post-study for 5 years during routine clinic follow-up for time to first recurrence, overall survival, and site of first recurrence and incidence of isolated scalp metastasis.