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Evidence builds for scalp cooling

Monday, June 19, 2017

Tessa Cigler, M.D. uses cold caps to preserve hair during chemotherapyTessa Cigler, M.D. Photo credit: Jesse Winter Growing evidence suggests that scalp cooling can alleviate chemotherapy-induced hair loss. The most recent data come from a study in which two-thirds of patients who underwent scalp cooling retained half or more of their hair.

“Enabling a woman to preserve her hair during chemotherapy is empowering,” said lead investigator Tessa Cigler, M.D., MPH, an assistant professor of clinical medicine in the Weill Cornell Breast Center, Weill Cornell Medicine, in New York City. “Scalp cooling allows patients to protect their privacy and maintain their self-esteem and sense of well-being. This study provides long-awaited evidence for an effective and practical scalp-cooling method.”

The study included 122 women with stage 1 or 2 breast cancer who received non-anthracycline adjuvant chemotherapy. The average duration of chemotherapy was 2.3 months. Scalp cooling, received by 101 women, began 30 minutes prior to each chemotherapy cycle and involved a close fitting of a silicone cap on the patient’s head, with an insulating neoprene cap on top of he silicone cap. The silicone cap was then gradually cooled. The DigniCap (Dignitana AB) is set to cool at 3° C, with a variance of plus or minus 2°.

Self-estimated hair loss was assessed four weeks after the last dose of chemotherapy by unblinded patient review of five photographs. Treatment success was defined as 50% or less hair loss (Dean score, 0-2). Quality of life was assessed at baseline, at the start of last chemotherapy cycle and one month later. The median duration of follow-up was 29.5 months.

In the scalp-cooling group, 66.3% of patients retained half or more of their hair whereas no patients in the control group did (95% CI, 56.2%-75.4%; P<0.001). Three of five quality-of-life measures were significantly better for the women who underwent scalp cooling. Of the patients who underwent scalp cooling, 27.3% reported feeling less physically attractive compared with 56.3% of controls (P=0.02). Of the 106 patients in the scalp-cooling group, 3.8% experienced a mild headache and 2.8% discontinued due to feeling cold. There was no evidence of scalp metastases in any patient after approximately 30 months of follow-up.

Scalp cooling is thought to reduce hair loss by reducing delivery of chemotherapy to the scalp and hair follicles. The cold temperature is also thought to slow hair follicle cell division, making the cells less susceptible to the damaging effects of chemotherapy.

DigniCap, cleared by the FDA in December 2015 for use on women with breast cancer based on preliminary results from Dr. Cigler’s study, is the only FDA-cleared device in the United States, but others are expected to enter the market. Scalp cooling has been used for several decades in Europe, but it has been slow to catch on in the United States because of insufficient scientific data and the theoretical concern that it could increase scalp metastases.

However, according to Julia R. Nangia, M.D., an assistant professor of medicine at Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine, in Houston, scalp metastases as a single site of recurrence is exceedingly rare, and studies involving thousands of patients demonstrate that the technology is safe.

At the 2016 San Antonio Breast Cancer Symposium, Dr. Nangia reported results from the Scalp Cooling Alopecia Prevention trial, the first randomized trial of a scalp-cooling device. This study tested the Paxman Hair Loss Prevention System and included 235 women with stage 1 or 2 breast cancer who received neoadjuvant or adjuvant taxane and/or anthracycline-based chemotherapy. In an interim analysis of 142 patients, half of the women using the device did not experience hair loss that required a wig, whereas all the women in the control group needed a wig.

This article first appeared in Clinical Oncology News. Read the original here.

Additional coverage:

Cooling Cap to Prevent Hair Loss Now for All Solid Tumors - Medscape

FDA Approves Expanded Use of Cooling Cap for All Solid Tumor Patients - Rare Disease Report