Chemotherapy-induced hair loss can be stressful and upsetting for a woman who is already contending with the physical toll of cancer treatments, but a new cooling cap is making waves with its groundbreaking ability to significantly reduce hair loss.Called the Dignicap, the invention is a two-part layering system. The inner skull-like cap contains tubes attached to a machine that pumps in coolant at 41 degrees Fahrenheit, while a cushioned outer cap locks in and preserves the refrigeration effect. The cap is worn before, during and after chemotherapy sessions for best results.So how does it work? By reducing the amount of blood flow to hair follicles, the DigniCap effectively constricts the blood vessels with a controlled and sustained blast of cold air. Less blood flow means that fewer toxic chemicals will reach the scalp and damage hair follicles, which is what causes hair to clump out.RESEARCH: Why Other Women Experience Hair LossAlready widely used in Europe, Swedish parent company Dignitana has most recently tested the device in Japan, where an eye-opening 83 percent of a 255 women group undergoing breast cancer chemotherapy sessions reported keeping most of their hair.The initial U.S. pilot study is currently underway at the University of California, San Francisco, where oncologist and professor Hope S. Rugo, M.D. is the lead overseer. Rugo says the goal is to eventually receive FDA approval, and so the team is working closely with the FDA on the study design and results analysis.In the current study of 20 women with breast cancer, photographs are taken during and after chemotherapy to track hair loss and preservation, as is data on how well the patient is able to tolerate the cooling system. Side effects are also tracked. The hope is that the next, more complete study involving a target 100 women will be approved based on the results of the preliminary one. If that happens, final FDA approval could be just a few years away.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.RESEARCH: Exercise Helps Lower Breast Cancer Risk“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.QUIZ: How Healthy is Your Hair?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.