Scalp Cooling to Prevent Chemo Hair Loss Shows Promise

Cooling the scalp before, during, and after chemotherapy with a proprietary scalp cooling device prevents hair loss in at least 50% of women being treated for early-stage breast cancer, although success may depend on the type of chemotherapy women receive and how skilled clinicians are in applying the cooling device.

Two separate studies of two different scalp cooling devices for the prevention of chemotherapy-induced alopecia were published online February 14 in JAMA Oncology. Both report positive results, showing that the devices do prevent some hair loss.

As the investigators explain, lowering the temperature of the scalp constricts blood vessels, reducing both blood flow and the amount of chemotherapy delivered to the hair follicles, which in turn reduces the amount of hair loss.

"At face value, these findings appear to represent a major step forward in improving the quality of life of individuals with cancer," comments Dawn L. Hershman, MD, from the Herbert Irving Comprehensive Cancer Center at NewYork–Presbyterian/Columbia University Medical Center, New York City, in an accompanying editorial.

However, she adds that the quality-of-life results need to be interpreted with caution. In addition, there are also questions about who will pay for these scalp cooling devices because this is a treatment for temporary hair loss, which "can be perceived as cosmetic."

Yet, she argues, "[o]ne of the strongest deterrents for a woman who is deciding whether to undergo chemotherapy is concern about alopecia."

In fact, an estimated 8% of women who might benefit from chemotherapy have indicated that they would refuse treatment because of their fear of hair loss, she adds.

"[I]dentifying interventions, such as scalp cooling for the prevention of chemotherapy-induced alopecia, that reduce or eliminate treatment-associated toxic effects will help ease the distress associated with chemotherapy and may, as a result, improve outcomes for patients with breast cancer," Dr Hershman concludes.

Author of a second editorial and JAMA Oncology web editor, Howard (Jack) West, MD, Swedish Cancer Institute, Seattle, Washington, agreed, telling Medscape Medical News that clinicians have not prioritized hair preservation during chemotherapy as much as they perhaps should have based on what matters to patients.

Hair loss is not a trivial consequence of chemotherapy for many patients, he emphasized.

"I think many people, especially women, may factor the potential for alopecia into their decision about receiving chemotherapy, and this could potentially lead to patients being undertreated because of their concerns about this side effect," he said.

"And given that patients are key decision makers in their treatment, I think it really helps when we can demonstrate that we are listening to their concerns and do things to minimize issues that are of greatest concern to them," he added.

SCALP Trial With Paxman Device

One of the trials used the Orbis Paxman Hair Loss Prevention System (Paxman Coolers Ltd), which is awaiting approval in the United States.

The Paxman device is a two-cap system consisting of an inner silicon cap in which refrigerated fluid is circulated and an outer neoprene cap that insulates the scalp. The cap is fitted snugly to the head and is held in place with a chin strap.

This device was tested in the Scalp Cooling Alopecia Prevention (SCALP) trial, and  initial results were reported by Medscape Medical News from the San Antonio Breast Cancer Symposium in 2016. They are now published, with lead author Julie Nangia, MD, Baylor College of Medicine, Houston, Texas.

The SCALP trial was conducted in 142 evaluable patients who were randomly assigned to the device or to usual care for the duration of four cycles of chemotherapy. Sixty-four percent of women received a taxane-based regimen and 36% received an anthracycline-based regimen.

Scalp cooling with the device was carried out for 30 minutes before, during, and for 90 minutes after each chemotherapy infusion, the researchers explain.  For these patients, a comfort scale questionnaire was administered after each session.

"Based on the comfort scale, most patients were comfortable, reasonably comfortable, or very comfortable while wearing the device," the investigators observe.

Treatment was deemed to be a success if clinicians blinded to randomization judged patients to have experienced no hair loss or only grade 1 hair loss (<50% hair loss not requiring a wig), as defined by the Common Terminology Criteria for Adverse Events version 4.0 (CTCAEv4.0) alopecia scale.

At the time of the planned interim analysis, 95 women had been treated with the scalp cooling device and 47 others had received no specific treatment for alopecia.

Results showed that after the fourth cycle of chemotherapy, 50.5% of the cooling group retained their hair, achieving a grade 0 or 1 on the CTCAEv4.0 scale — meaning no wig or scarf was needed — vs 0% of controls.

That said, 63% of women randomly assigned to the scalp cooling group still resorted to wearing a wig or a head wrap (100% of women in the control group similarly wore a wig or head wrap), and no differences in emotional or social functioning at the end of chemotherapy were observed between the two groups.

Variable Results

Success in terms of hair retention varied by both the type of chemotherapy participants received and what would appear to be clinician expertise in using the device.

For example, hair preservation rates were much lower (16%) among women who received an anthracycline-based regimen than among those who received a taxane-based regimen (59%).

Furthermore, depending on the center where women received treatment, success ranged from a low of nearly zero to over 68%, investigators add.

As the authors explain, the variability seen in hair preservation rates by study site may have had a lot to do with the way the cap was used.

"The fit of the cap is key to successful hair retention with the scalp cooling device," Dr Nangia and colleagues explain, "and there is a learning curve with use of the device; with repeated use, clinicians become more skilled at ensuring a tight fit and there is a higher likelihood of hair retention."

Thus, hair retention rates among women who were enrolled later on in the study, when investigators were more aware of the optimal technique with which to maximize hair preservation, may have been higher, they speculate.

Study With DigniCap

The second published study used a different scalp cooling device, the DigniCap, developed by Dignitana AB). This device was cleared for use in the United States in 2015, and initial results from this study were reported at the time by Medscape Medical News.

In this study, Hope Rugo, MD, University of California, San Francisco, and colleagues assigned 106 women with early-stage breast cancer to use the DigniCap device, and another 16 women served as controls.

Importantly, almost all women in this study received some form of taxane-based chemotherapy, and no women in the scalp cooling group received an anthracycline-based regimen. The mean duration of chemotherapy in this particular study was 2.3 months.

"Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward," the authors explain.

Only 3.8% of women in the scalp cooling group reported having a mild headache from the procedure, while 3 patients discontinued treatment because of feeling cold, the researchers note.

In this study, the percentage of hair loss was assessed by using the so-called Dean scale, on which a score of 0 signifies no hair loss and a score of 4 represents hair loss in excess of 75%.

Patients assessed their own hair loss by comparing photographs of themselves taken at baseline with those taken during the current chemotherapy cycle. Hair loss was assessed 4 weeks after completion of all planned cycles of chemotherapy.

Of 101 evaluable patients assigned to the scalp cooling group, 66.3% experienced hair loss of 50% or less from baseline, meaning they had a Dean score of 0 to 2 at study endpoint.

This compared to 0% of women in the control group (P < .001), Dr Rugo and colleagues note.

Indeed, in an interim analysis, 15 of the 16 women in the control group had a Dean score of 4 and recruitment to the control group was terminated.

"Among all patients, there were significant between-group differences 1 month after chemotherapy for 3 of 5 quality-of-life measures," the authors observe.

For example, about one quarter of patients in the scalp cooling group acknowledged that they felt "less physically attractive" after undergoing chemotherapy, compared with over half of controls (P = .02).

At a median follow-up of 29.5 months from the patients' last chemotherapy session, there has been no evidence of scalp metastases among the scalp cooling group.

Results reported by Dr Rugo et al with DigniCap Device

Fear of scalp metastases has been cited as one of the main reasons why scalp cooling devices have not been widely adopted in the United States,  unlike in Europe, where they have been used for decades.

"In this study, patients in the scalp cooling group felt less upset about losing their hair compared with patients in the control group and were less dissatisfied with their body," Dr Rugo and coauthors write.

"These data suggest that when scalp cooling is successful at decreasing hair loss, it could improve the treatment experience for women undergoing adjuvant chemotherapy for early-stage breast cancer," they add.

Long-term follow-up of Rugo and colleagues' study is ongoing.

The study by Dr Nangia et al was supported by Paxman Coolers Ltd, which contracted with Baylor College of Medicine to conduct the study.  The study by Dr Rugo et al was partially funded by Dignitana AB. Dr Nangia and Dr Rugo have disclosed no relevant financial relationships, but several coauthors on each study have relationships with industry, as listed in the papers. Dr West and Dr Hershman have disclosed no relevant financial relationships.

JAMA. Published online February 14, 2017. Nangia study abstract, Rugo study abstract, Hershman editorial extract, West editorial extract

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Cite this: Scalp Cooling to Prevent Chemo Hair Loss Shows Promise - Medscape - Feb 14, 2017.