Industry insiders say the reason there has been a delay passing FDA approval in the U.S. when Europe has had open access to the device for years relates to concerns that cancer cells could theoretically hide out in the scalp since chemotherapy is not being delivered there. However, Rugo disagrees based on her professional experience and research studies.
“There is no evidence that in breast cancer there is any increase in risk of scalp metastases. Scalp metastases are very rare, and large databases have not shown an increase in this finding,” says Rugo. “Also, we believe that breast cancer cells hide out in the bone marrow and other solid organs, rather than in the scalp.”
However, some cancer patients are not candidates for the Dignicap. Those who have leukemias or lymphomas are not treated, as those cancer cells are commonly scattered throughout the body, and reducing chemotherapy treatment to the scalp could put the patient’s survival at risk.
So far, Rugo says the most common side effect is headache and not surprisingly feeling frigid, which her team attempts to circumvent with a warm blanket and a small amount of pain medication to get the patient through the most challenging first 30 to 60 minutes of the cooling process. Hair loss is also still to be expected, though at a sizably reduced level. “Everyone loses some hair, some more than others. But it prevents complete alopecia,” says Rugo.
While the Dignicap is the first hair loss reduction device poised to go mainstream, the concept of scalp cooling to prevent chemotherapy hair loss is not new. Some physicians have experimented with devices on willing patients, as was the case with Tammy Ross decades ago. Ross is today an office manager with a small manufacturing firm in Staunton, VA.
Diagnosed with breast cancer at the age of 30 in 1989, Ross volunteered to try a so-called “cold cap” that Denver, Colorado doctor Eduardo R. Pajon, M.D. offered at the time. Looking much like a terry cloth tea cozy with gel in the center, the cap would be kept in the freezer until use, and then put on for 15 minutes before chemotherapy, kept on during treatment, and for an additional 15 minutes afterwards.
Ross says the results were better than she could have ever imagined.
“Instead of clumping out, my hair very naturally thinned. I had my hair cut into layers, and absolutely no one was aware that I had lost any,” says Ross. “It also came back with a wave I never had before. It was as straight as a board despite perms until chemo. At least something good came from it that way. And I’m still alive!” adds Ross, now over 22 years later.
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