Baylor Team Helps Establish Scalp-Cooling Benefits for Breast Cancer Patients

Julie Rani Nangia, MD
Published: Thursday, Aug 31, 2017
dan-duncanJulie Rani Nangia, MD
Assistant Professor
Lester and Sue Smith Breast Center
Dan L. Duncan Comprehensive Cancer Center
Baylor College of Medicine
Houston, TX
Strategic Partnership
One of the most traumatic and outwardly visible adverse effects for many women undergoing chemotherapy treatment for breast cancer is hair loss. Supported by research, there have been recent developments in using scalp cooling to combat chemotherapy-induced alopecia.

We published a paper in JAMA earlier this year to report the results of multisite research studying the effectiveness of scalp-cooling therapy in reducing hair loss in women undergoing taxane or anthracycline chemotherapy regimens.The Baylor team included Mothaffar F. Rimawi, MD, medical director of the Lester and Sue Smith Breast Center.

Because hair loss takes a tremendous toll on a patient’s body image, and the individual no longer has the anonymity of hiding the disease, everyone can see that she is sick. Patients and physicians have been hoping and searching for methods or therapies to prevent or reduce hair loss due to chemotherapy, but the options have been very limited because of the complexity of the disease and the treatment.

Our Scalp Cooling Alopecia Prevention trial (SCALP) used 1 cooling cap, the Paxman Hair Loss Prevention System, a product of Paxman Coolers, Ltd. The device, which has been cleared by the FDA, operates using a 1- or 2-cap system, with the inner silicone cap circulating a refrigerated fluid and the outer neoprene cap insulating the scalp and fitting snugly to the patient’s head with a chin strap. Both caps are fitted once and worn for the duration of the chemotherapy treatment session. The 2-cap system ensures the coolant stays at a constant temperature; it is connected to a small machine, which can be briefly detached from the patient to allow for greater mobility during sessions.

The study involved 7 trial sites across the country and enrolled 182 women with either stage I or II breast cancer who planned to have at least 4 cycles of either taxane- or anthracycline-based chemotherapy. They were randomized in a 2:1 ratio to determine whether they received the scalp-cooling device or no cooling therapy.

The primary objective of our trial was to determine the safety and efficacy of the scalp-cooling device in reducing hair loss in patients undergoing chemotherapy. Secondary endpoints included whether patients in the cooling arm required use of a wig or scarf and overall quality of life.

Prior to the SCALP trial, there had been no randomized studies assessing modern scalp cooling to prevent alopecia, and the results from similar nonrandomized trials have varied historically. Scalp-cooling devices provide a more effective, steady delivery of cooling therapy to the scalp than do cold caps, which are not devices, must be changed out frequently during chemotherapy administration, and vary in temperature.

Patients in the trial who received scalp cooling wore the device for 30 minutes prior to their chemotherapy treatment, for the duration of their treatment, and for 90 minutes following treatment.

Although chemotherapy treatment works by attacking rapidly dividing cells, such as cancer cells, it also targets rapidly dividing hair cells. Since 90% of these hair cells are in the growth stage, hair loss can result. Scalp cooling lowers the temperature of the scalp, thereby constricting the blood vessels and reducing the flow of blood to the hair follicles, which will help reduce hair loss by limiting the amount of chemotherapy drugs reaching the follicles.

With a 50.5% success rate in the provisional analysis after 4 cycles of chemotherapy, our trial’s results crossed the superiority boundary and resulted in the study being halted early because of efficacy. As the cap becomes more widely used, best practices will be developed to ensure maximum results.

Updated Findings Confirm Benefit

In the final analysis that we recently presented at the 2017 American Society of Clinical Oncology Annual Meeting, 130 patients in the cooling group and 54 patients in the non-cooling group were evaluable and had completed 4 cycles of chemotherapy.

Among them, 53.1% of patients in the cooling group had hair preservation of grade 0 or 1 after 4 cycles of chemotherapy, meaning no wig or scarf was needed, compared with 0% in the non-cooling group.

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