An experimental method of preventing one of the most emotionally difficult side effects of cancer treatment has finally come to Houston: a scalp-freezing technology touted to stop hair loss caused by chemotherapy.
Baylor College of Medicine researchers are recruiting newly diagnosed breast cancer patients to test one of the new hair-preserving systems, which are already in use in Europe but are just now beginning to be studied in the U.S.
The Houston school is the lead site of the multi-institutional trial.
“I’m hopeful this trial proves the system works like it does in Europe so it can receive Food and Drug Administration approval and become available here,” said Dr. Julie Nangia, a professor in Baylor’s Lester and Sue Smith Breast Center and the trial’s primary investigator. “When cancer patients lose their hair, they lose their anonymity, which can make going through treatment even harder.”
As part of the trial, Nangia is collecting information on patients’ psychological state – depression, anxiety, body image – as they undergo treatment, to determine whether their psyches fare better if they keep their hair. Such information could provide justification for insurance to cover the system, she said.
The method involves a hypothermia, or cold, cap tightly fitted on the patient’s head before, during and after each session of chemotherapy. Chemo attacks not just cancer cells but also healthy cells, particularly rapidly dividing ones such as those in hair roots. The idea behind scalp freezing is that the cold both constricts blood vessels so less chemotherapy is delivered to hair follicles and decreases chemotherapy’s enzyme activity that drives the attack on cells.
But the method is unproven in the United States, and its effect on chemotherapy has even caused a little concern it could lead to cancer’s spread to the scalp. Scalp metastasis is very rare, however, and long-term studies out of Europe have found no higher rate of such cancers among patients who’ve used cold caps.
The subject of much recent buzz, scalp-freezing actually has been around for more than 20 years. The early models, still used, were low-tech – frozen caps worn for 15 to 20 minutes, then continuously replaced with another, usually by the patient’s spouse, or a friend.
Most clinics still accommodate patients who bring their own rented caps, which don’t require FDA approval since they’re not a device. Such patients are relatively rare in the U.S., say Baylor and M.D. Anderson Cancer Center doctors.
Even where it’s not used, scalp-freezing is considered an appealing idea.
“Enabling patients to keep their hair would be a wonderful thing,” said Dr. Carmen Escalante, chair of the department of general internal medicine at M.D. Anderson, which does more clinical trials than any institution in the country but has never done one on hypothermia caps. “Someone just needs to answer the question of whether freezing the scalp works. Currently, there isn’t sufficient data.”
The Baylor study is testing the Paxman Hair Loss Prevention System, which consists of a mobile refrigeration unit that circulates a chilled liquid coolant through a specially designed cooling cap (manufactured from silicone, provided with a neoprene cover).
One cap, maintained at an even, constant temperature, stays on the patient the entire time.
Baylor started accruing patients for the study in December 2013, after the launch of a study of the DigniCap System, a competitor that also uses a cooling machine to pump liquid coolant through the cap.
That study is being conducted at the University of California-San Francisco, UCLA, North Carolina’s Wake Forest Baptist Medical Center and Weill Cornell and Beth Israel medical centers in New York.
After a Houston patient who’d read about Paxman’s results in Europe pushed for the device, it took more than three years before the FDA granted Nangia permission to conduct the trial.
The trial now has 73 patients total between Baylor, Memorial Hermann-Memorial City, the Baylor Charles A. Sammons Cancer Center at Dallas, the Cleveland Clinic and Morristown Medical Center in New Jersey. Nangia hopes to add more sites this summer.
Among the satisfied customers was Nadine Riggs, who finished her treatment in October with almost all her hair extant.
“At diagnosis, I wasn’t that concerned about losing my hair, at least to the extent some women are, but when I heard there was technology to keep it, I thought that sounded great,” said Riggs, a Dallas human resources professional. “I’d definitely recommend the device to patients upset at the idea of losing their hair. Except for the start, I barely noticed I had the cold cap on.”
The start is compared to jumping in a cold pool, but most patients acclimate quickly, said Nangia. The unit maintains a 25 degree F temperature, which is downright temperate compared to the below zero temperatures to which the standalone caps are cooled, temperatures that cause patients to really bundle up for their chemotherapy session.
Nangia also thinks the new system will be less expensive and covered by insurance. The standalone caps, which insurance doesn’t cover, rent for about $600 a month.
Still, the method is far from a slam dunk, despite Riggs’ happy experience. Most patients’ hair still thins, and in overseas studies, the method prevented significant hair loss in only 40 percent to 70 percent of subjects.
Nangia’s definition of success for this study is to prevent significant hair loss in at least 25 percent of patients.
Still, Nangia is hopeful to have positive enough data to submit for FDA approval in late 2016. If this trial proves successful, she wants to conduct a follow-up trial open to all solid tumors. The method is not considered safe for blood tumors.
“Losing your hair isn’t just a cosmetic concern,” said Nangia, noting that baldness acts as a declaration to everyone around that the woman has cancer. “It can be quite devastating for some patients. For some I’ve treated, the only time they ever cried was when they lost their hair.”