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

Julie Rani Nangia, MD

Assistant Professor

Lester and Sue Smith Breast Center

Dan L. Duncan Comprehensive Cancer Center

Baylor College of Medicine

Houston, TX

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.

Updated Findings Confirm Benefit

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.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.

Within the cooling group, scalp cooling was particularly effective in preserving hair in women undergoing taxane chemotherapy, with a retention rate of 63%. At the completion of chemotherapy (up to 8 cycles), 46.2% of study participants in the cooling arm retained their hair, including 64.6% of those undergoing taxane therapy.

Throughout the trial, mild adverse effects such as headaches and temporary discomfort were reported. Patients involved in the scalp-cooling study will be followed for 5 years to determine longer-term efficacy and any adverse effects, including scalp metastases, along with recurrence and overall survival.

We focused this study on women with breast cancer because of its prevalence and large patient population and because women are emotionally sensitive to hair loss in general. Preventing hair loss may improve patients’ emotional well-being and help them maintain a degree of privacy.

The final results of the trial show that scalp cooling using the Paxman Hair Loss Prevention System is highly effective in hair preservation for patients who receive chemotherapy for stage I or II breast cancer.

Nangia J, Wang T, Osborne C, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: the SCALP randomized clinical trial. JAMA. 2017;317(6):596-605. doi:10.1001/ jama.2016.20939.