Covering cancer patients' heads with an ice-cold cap could prevent chemotherapy-related hair loss.

The cap works by freezing the top of the head, which may prevent the hair-thinning chemotherapy drugs from reaching the area by slowing blood flow, Bloomberg via the Associated Press reported.

Cold cap treatments have not yet been approved by the Food and Drug Administration (FDA) in the U.S., one concern is the treatments could keep the medicine from reaching stray cancer cells in the scalp.

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

Despite FDA concerns, Americans have been renting what are known as "Penguin Cold Caps" for $455 per month from a British company.

The cold treatments cannot be administered by health professionals, so patients bring their own caps on beds of dry ice. They are often accompanied by a friend who helps switch their cap to a colder one every 20 to 30 minutes. Hospitals sometimes provide a special freezer to aid in the process.

Miriam Lipton, a breast cancer patient, tested out the treatments back in 2011. The first time she underwent chemotherapy most of her hair fell out. When she needed treatment for a second time she used a cold cap and saw real results.

"I didn't necessarily want to walk around the grocery store answering questions about my cancer," Lipton said. "If you look OK on the outside, it can help you feel, 'OK, this is manageable, I can get through this."'

Twenty U.S. patients tested out the "DigniCap" in 2011, most of the participants kept more than half their hair.

Lipton, who participated in the trial, noticed her hair thinned the most at the top of her head, where the cap was looser. She was able to cover it with a headband instead of a wig or scarf.

Later this summer, several hospitals in New York and California will conduct a larger study on the cold cap treatments.

The company Dignitana that produces the Dignicap, said the process works when "the temperature of the scalp is lowered. The cold gives reduced perfusion, delivery of blood, and metabolism. The reduced blood flow gives a smaller amount of chemotherapy available for uptake in the cells and the decreased temperature results in less absorption and reduced effects of chemotherapy. These factors together reduce the risk of hair loss."

The study will observe 110 early stage breast cancer patients using the DigniCap during chemotherapy. The cap attaches to a cooling machine that keeps the scalp at a temperature of 41 degrees, Bloomberg via the AP reported.

The progression of the patient's hair loss will be documented through photographs, which will then be assessed by experts, and compared with patients who did not use the DigniCap.

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