WINSTON-SALEM, N.C. -- Results from a local clinical trial provide a sense of hope for cancer patients.
Doctors say, any day now, the FDA could approve a medical device that helps cancer patients keep their hair while undergoing chemotherapy.
"I would cry for hours. I didn't want it to happen,” cancer survivor Melissa Calloway said as she remembered the fear of losing her hair.
She says being diagnosed with stage one breast cancer was rough.
Learning she would have to have chemotherapy was also hard.
But the thought of losing her hair was overwhelming.
"There was something about going out in public and being bald and people knowing your story when you weren't willing to tell it to everyone,” she said.
After doing research on the Internet, she found an option.
Melissa Calloway participated in the second clinical trial of the DigniCap system offered at Wake Forest Baptist Medical Center.
The DigniCap system uses scalp cooling technology to help prevent chemotherapy-related hair loss.
Calloway was one of 15 participants who tested the cap in September 2013.
"I had four rounds of chemotherapy. When I would show up for each cycle, I would have the cap put on for approximately 30 minutes before the chemo started,” she said.
The trial focused on patients with early stage breast cancer.
The FDA would consider the study a success if patients reported losing less than half of their hair.
"70 percent of patients felt it was a success, that they had lost less than 50 percent of their hair,” Dr. Susan Melin, associate professor of hematology and oncology at Wake Forest Baptist Medical Center, said.
Calloway lost 40 to 45 percent of her hair, but considering that most chemotherapy patients lose 90 percent if not all of their hair, she was pleased.
"I was upset by it, but still I had hair. I could put a baseball cap on and pull a ponytail through and just having that helped my self-esteem,” she said.
Trial results, including from participants at Wake Forest Baptist, were released this month at the American Society of Clinical Oncology’s (ASCO) meeting in Chicago.
Swedish company Dignitana produces the cooling system and it’s currently available for clinical use throughout Europe, Canada and Japan.
Melin and Calloway hope the United States will be added to the list soon.
“To have that available here to women in the United States and to know that’s one less thing that cancer is going to take from you, I think it's phenomenal and I'm excited,” Calloway said.
The clinical trial for the DigniCap is no longer available. The machine Wake Forest Baptist was using has been shipped back to Sweden.
The hospital hopes to be selected as a treatment location pending FDA approval.
In terms of side effects, some reported experiencing headaches.
According to Dignitana’s website, the cooling cap is not compatible with all forms of chemotherapy.