Scalp Cooling Safe, Long-term European Data Show

May 4, 2016 6:31 pm

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Scalp Cooling Safe, Long-term European Data Show

For cancer patients undergoing alopecia-inducing chemotherapy, scalp cooling to reduce hair loss is safe, according to new research. “This is a treatment that women going into chemotherapy treatment need to know about,” said Mikel Ross, RN, BSN, from the Memorial Sloan Kettering Cancer Center in New York City. “Patients are asking for this.”

The technique, which has been used in Europe since the 1970s, was only approved by the US Food and Drug Administration in December 2015, but doctors and nurses in the United States have yet to embrace it.

They are holding on to a 40-year-old belief that the treatment is unsafe and that it can result in scalp metastases, Ross told Medscape Medical News. “That has to change.”

The issue of hair loss during chemotherapy should not be taken lightly. “More than 75% of women see hair loss as the most feared side effect of chemotherapy,” he said, citing one study in which 10% of patients said they would consider refusing chemotherapy or consider a less effective treatment to avoid hair loss.

Although scalp cooling appears to be safe, the 50% success rate and the discomfort make women think twice about using it — not to mention cost. Still, doctors and nurses need to pass on better information so that patients can make an informed decision, he explained.

Ross presented an examination of 40 systematic reviews, comparative trials, and publications on scalp cooling at the Oncology Nursing Society 2016 Annual Congress in San Antonio.

An analysis of two Dutch studies — one a scalp cooling registry of 1411 patients (Acta Oncol.2012;51:497-504) and the other a systemic review of 50,000 breast cancer patients (Breast.2013;22:1001-1004) — concluded that scalp metastases are rare. This is the most common safety issue cited by doctors about the treatment, Ross reported, but the research shows an incidence rate of scalp metastases of about 1.0% in patients who use cooling and in those who do not.

In fact, in a review of 49,711 patients, 0.04% to 1.00% who were treated with cooling developed scalp metastases, as did 0.30% to 3.00% of those who were not treated with cooling (Breast.2013;22:1001-1004).

In addition, in a retrospective review of 640 patients from Quebec, Canada, rates of scalp metastases were similar whether or not scalp cooling was used (1.1% vs 1.2%) (Breast Cancer Res Treat.2009;118:547-552).

“We need to catch up on the research and change our thinking,” Ross said.

Success with the technique — defined as a woman not having to wear a wig or head covering at her final chemotherapy treatment — ranges from 10% to 100% (Breast.2011;20[Suppl 1]:S80).

In general, however, “the research shows that 50% of women reduce their hair loss and don’t feel they need to cover their head on their last day of chemotherapy,” Ross reported.

Variability in success rates depends on a host of determinants, including chemotherapy type and dose, cooling system used, and patient-specific variables. And metabolic differences and differences in hair quality might also have an effect.

“There are no core data on textured vs straight hair, or whether curled hair does better,” Ross said. “But we found that if you cool, you will keep more than if you don’t; the rest is a gamble.”

It’s a viable option, and most important, “the data suggest that it’s safe,” he added.

Still, the treatment is not for everyone. One version of scalp cooling — cold cap therapy — requires that the caps be frozen in dry ice or a freezer and be changed every 20 to 30 minutes. It is recommended that the caps be worn 1 to 2 hours before and about 3 hours after chemotherapy treatment. That means a 2- to 3-hour chemotherapy session can turn into a 6- to 8-hour sitting requiring about 22 caps.

In contrast, cooling systems such as Paxman and DigniCap use a refrigeration machine to continually cool the cap while it is being worn by the patient, eliminating the need for cap changing.

It’s cold, it’s uncomfortable, it’s boring, and can make a chemotherapy session very long, Ross pointed out. However, overall tolerability is high.

“Scalp cooling caps are available now in the United States, and machines will be available in the next year or so,” he said.

Currently, patients can rent cold caps for about $580 a month, but they also need a freezer or dry ice at the hospital and someone to help with the frequent cap changes. “Cost is the fly in the ointment; it’s not covered by Medicare because it’s considered cosmetic. But I think that’s likely to change,” Ross said.

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