FDA Clears Multicenter Trial of Treatment for Hair Loss Related to Chemotherapy

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The FDA has approved initiation of a multicenter trial of the DigniCap System, a scalp-cooling device for chemotherapy-related hair loss. The trial is the second and final phase of study for the DigniCap System. A pilot study previously conducted by researchers at the University of California San Francisco and Wake Forest Baptist Medical Center found that the treatment was successful and well tolerated in the majority of women.

Multicenter Trial

Clinical trials will be conducted with 110 patients at major medical centers in the United States, including UCSF and Wake Forest. Two additional sites in New York and one in California are expected to open during the summer. To participate in the trial, patients must be 18 years of age and have a documented diagnosis of stage I or II breast cancer. Eligible patients must plan to complete chemotherapy within 6 months using standard chemotherapy regimens stipulated in the trial protocol.

“Hair loss is an inevitable side effect caused by [chemotherapy], and for many women this is the most emotionally distressing and disturbing impact from their diagnosis. A short course of chemotherapy results in total hair loss taking many months to grow back,” said Hope S. Rugo, MD, Principal Investigator for the study at UCSF and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center.

“Devices that can reduce hair loss have the potential to have a significant impact on patients’ quality of life, and this study is the first of its kind in the United States,” Dr. Rugo added.

Cap Reduces Risk of Hair Loss

The DigniCap System features a tight-fitting silicone cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the inner one. A coolant circulates throughout the inner silicone layer, delivering consistent cooling to all areas of the scalp. The system contains built-in temperature sensors and a precision cooling mechanism that allows for gradual scalp temperature fluctuations.

When a cap is applied to the head, the temperature of the scalp is lowered and blood vessels surrounding the hair roots contract, resulting in a significant reduction of cytotoxins to the follicle. Reduced blood flow leaves a smaller amount of chemotherapy available for uptake in the cells, and the decreased temperature results in less absorption of and reduced effects from chemotherapy. These factors together reduce the risk of hair loss.

Historically, cooling systems and cold caps have not been used in the United States because of concerns that the scalp cooling could allow cancer cells to hide in the scalp. However, based on a large review of published data, the use of scalp-cooling systems did not increase the already very low incidence of scalp metastases, Dr. Rugo reported. “We are carefully following patients using these systems in several clinical trials,” she said. ■