U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy.
Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer Hair may fall out entirely, gradually, in sections, or may become thin. Hair loss due to cancer treatment is usually temporary, but minimizing or relieving these kinds of side effects are considered important to overall treatment.
The DigniCap® system consists of a snug-fitting silicone cooling cap connected to a cooling and control unit.
The reduced temperature results in a reduced blood flow to the scalp area so that less chemotherapy reaches the hair cells. In addition, cellular metabolism within the hair cells is slowed down. Hair cells are therefore not exposed to the full dose of chemotherapy and may be able to survive the chemotherapy treatment.
Coolant circulates through channels in the cap. Sensors in the cap monitor scalp temperature allowing the system to automatically regulate cooling temperature throughout the treatment. To make this process more comfortable, the cooling cap is at room temperature when placed on the head and the treatment temperature is gradually achieved over a short period of time.
A separate safety sensor in the cap ensures that the temperature never drops below the freezing point of 32° F (0° C). To ensure optimal treatment temperature, an outer insulating cap of neoprene is applied over the silicon cap.
Key System Features
- Gradual cool-down from room temperature provides patient comfort
- Self regulating temperature control system automatically detects and adjusts cooling temperature based on the scalp temperature detected by two separate sensors built into the cap
- Two independently controlled continuous cooling systems enables simultaneous treatment of two patients
- Quick-disconnect allows caps to be easily detached from the machine to accommodate bathroom breaks
- Intuitive touch screen interface simplifies system operation for infusion center staff, allows time and temperature settings to easily be easily altered for different chemotherapy regimens and patient comfort.
- Flash memory, DIGNISTICK™, makes it possible to save data from each scalp cooling treatment and facilitates software upgrades.
- Image-Dignitana Inc.
Key Cap Features
- Smooth inner surface for optimal scalp contact
- Shaped to leave patients’ ears uncovered for comfort and ease of hearing
- Cap is at room temperature when fitted to the patient’s head for increased patient comfort.
- Available in multiple sizes to enable personalized fit for effective scalp cooling
- Patented dual sensor-monitored cooling channels (front and rear) for temperature management to ensure consistent, uniform cooling across the entire scalp.
- Outer neoprene cap, DigniTherm™ for optimal fit and treatment temperature
- Built-in security sensor ensures scalp temperature never falls below 32° F/O° C.
Safety & Efficacy
The efficacy of the cooling system was studied in 122 Stage I and Stage II women with breast cancer who were undergoing chemotherapy, using recognized chemotherapy regimens that have been associated with hair loss. The data from this study may also be applied to some Stage III and IV breast cancer patients because they may have a benefit-risk profile comparable to the patients enrolled in this study. The primary endpoint was a self-assessment of hair loss by the women using standardized photographs at one month (three-six weeks) after the last chemotherapy cycle. More than 66 percent of patients treated with the DigniCap reported losing less than half their hair.
The most common side effects of the cooling system include cold-induced headaches and neck and shoulder discomfort, chills, and pain associated with wearing the cooling cap for an extended period of time.
Manual Cold Caps
Prior to the FDA clearance of the DigniCap® system, the manual cold caps were the only real option for scalp cooling in the United States. These caps must be kept in special freezers or in coolers with dry ice. The caps are applied to the patients head already chilled down to -25°C which can cause significant discomfort. In addition, because the caps warm up during treatment, patients must be refitted with a new chilled cap approximately every 30 minutes.
Because manual caps are not cleared by the FDA, infusion centers are precluded from offering the manual cap treatments to patients. Patients have to manage all arrangements themselves, including renting or buying the caps from suppliers, arranging for a freezer or dry ice, transporting the caps and coolers back and forth to the infusion center for each treatment and arranging for assistance to refit the caps throughout treatment.
The DigniCap Cooling System is manufactured by Dignitana Inc., in Lund, Sweden.