In an effort to stave off chemotherapy-induced hair loss, researchers have developed a hat designed to limit blood flow and thus limit drug access to wearers' hair follicles.

The way it works is by keeping the cap at a shivery 41 degrees Fahrenheit while a person undergoes treatment, allowing for reduced blood delivery to the area.

However, while scalping cooling is not a new concept, the Food and Drug Administration has yet to approve its use in the United States. One of the main concerns surrounding the method is the possibility of cancer cells in the scalp going untreated.

"Do they work and are they safe? Those are the two big holes," American Cancer Society spokeswoman Kimberly Stump-Sutliff told the Associated Press. "We just don't know.

Which is why U.S. researchers are about to put the caps to the test through a rigorous test led by Dr. Susan Melin of North Carolina's Wake Forest Baptist Medical Center and Dr. Hope Rugo of the University of California, San Francisco.

Together, the scientists will enroll 110 early-stage breast cancer patients in a study using the cap manufactured by the company DigniCap. Pictures of the participants' hair will be taken before and half and then compared to a control group of patients.

However, for those who have already tried the system, they admit it isn't perfect, with headaches and pain accompanying the process.

Still, there is evidence that the cap works.

A recent review by oncologists in the Netherlands, for example, found the system did as it claimed, though with less success in the case of higher doses or with certain kinds of chemo, the AP reports.

Furthermore, researchers at New York's Weill Cornell Breast Center reported at a recent meeting of the American Society for Clinical Oncology that from just over a dozen patients who opted for the Penguin cap, just one lost enough hair for a wig.

In the end, Laura Esserman, a UCSF breast cancer specialist, argues that hair loss is not something doctors should brush to the side simply because the concerns aren't strictly medical.

"If it matters to our patients, it should matter to us," she said.