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.
“We are pleased to see a product for breast cancer patients that can minimize chemotherapy-induced hair loss and contribute to the quality of life of these individuals,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Managing the side effects of chemotherapy is a critical component to overall health and recovery.”
The Dignitana DigniCap Cooling System is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. It is a computer-controlled system that circulates cooled liquid to a head-worn cooling cap during chemotherapy treatment. The cooling cap is covered by a second cap made from neoprene, which holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling.
The cooling action is intended to constrict blood vessels in the scalp, which, in theory, reduces the amount of chemotherapy that reaches cells in the hair follicles (hair roots). The cold also decreases the activity of the hair follicles, which slows down cell division and makes them less affected by chemotherapy. The combined actions are thought to reduce the effect chemotherapy has on the cells, which may reduce hair loss. DigniCap may not work with some chemotherapy regimens. Interested patients should talk with their doctors.
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.
Prevention of hair loss in these patients may be a significant benefit to their quality of life, and the risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.
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.
The FDA reviewed data for DigniCap cooling system through the de novo classification process, a regulatory pathway for some low- to moderate-risk devices that are novel and not substantially equivalent to any legally marketed device.
The DigniCap Cooling System is manufactured by Dignitana Inc., in Lund, Sweden.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The Food and Drug Administration (FDA) issued this news release following its approval of the first cooling cap for the U.S. market. While undergoing chemotherapy, breast cancer patients may pursue courses of treatment with the DigniCap scalp cooling device to prevent hair loss.
The release does a few things well. It uses appropriate wording to describe hair loss, addresses the harms of the cooling system and establishes high up in the story the novelty of the medical device. But the report lacks crucial details when quantifying benefits, evaluating the quality of evidence and discussing costs. We don’t know if there was a control group in the study, what its limitations are and how much a course of treatment is. Another problematic point that was overlooked was the conflict of interest present in the clinical trial: DigniCap’s manufacturers collaborated with a private organization to conduct the research and to submit the FDA application.
Breast cancer is the second most common cancer in women, with about 230,000 new cases each year. Many of these patients undergo chemotherapy to treat their breast cancers, in which hair loss is a common side effect. This, in turn, could negatively impact a woman’s self image.
Mitigating the side effects of chemotherapy is a worthy goal. Clinicians often focus on side effects that may be associated with compromising the ability to complete treatment or lead to physical harm. Here the focus is more on psychological harm and quality of life during treatment. It isn’t clear how many women may elect not to undergo chemotherapy who could otherwise benefit from it if they were less worried about hair loss. A non-invasive, effective therapy preventing hair loss from chemotherapy could be newsworthy, since current interventions include medications and hair transplant or restoration surgery. A cooling cap is not yet on the US market and may provide a viable alternative for women, especially for those who have already responded poorly to existing treatments.
The cost of therapy is not mentioned in the news release. Media reports have said prices will depend on how often the cap is used during chemotherapy, but it’s likely a course of treatment will cost between $1,500 and $3,000.
According to DigniCap’s website, the company is working toward getting the treatment covered by health insurance. It also states, “Dignitana is in the process of setting up a Patient Assistance Program to help subsidize DigniCap® treatment costs for patients with financial need.” Since there is no discussion of costs in the FDA news release, we give it a Not Satisfactory rating here.
We would have liked some more information here. Although the news release says: “More than 66 percent of patients treated with the DigniCap reported losing less than half their hair,” we don’t have a comparison to the control group. Without treatment, how much hair do patients actually lose?
There are other unanswered questions: How many times throughout the month did patients have to wear the caps to prevent hair loss? How long will patients have to undergo this therapy? And how long will the benefits last? How did the rate of hair loss compare with women who didn’t use the cap?
In addition, the patients themselves assessed how much hair they actually lost based on photographs and questionnaires, making this step prone to recall bias. Since this also was not a double-blind trial, this could have also introduced other biases into the data.
The news release addresses the most common known side effects of the cooling system, which included cold-induced headaches, as well as neck and shoulder discomfort, chills and pain associated with wearing the cooling cap for an extended period of time.
It also mentioned another risk: the cold cap could cause chemotherapy drugs to “miss” an isolated grouping of breast cancer cells in the scalp. However, the release points out that this is “extremely rare.”
Although we would have liked some evidence-backed explanations on the latter harm, we feel the news release does a Satisfactory job here.
In the “Quantify Benefits” section, we touched upon some biases that may have been present in the trial. And since patients knew which treatments they were receiving, this could have also skewed the results.
Other study limitations included short follow-up time, small study size and variability in size between the treatment versus no treatment groups. Patients determined how much hair loss they experienced between three to six weeks after their last chemotherapy cycle. There were 101 patients in the cooling cap group, while only 16 women were in the control group. It may have also been helpful to compare the cooling cap group to another established therapy, such as minoxidil (brand name Rogaine).
The news release also does not mention whether certain chemotherapy regimens were more likely to respond to treatment. According to DigniCap’s website, success was documented in 83.3% (p=0.022) of patients receiving docetaxel/carboplatin, 60.2% (p<0.001) of those treated with docetaxel/cyclophosphamide and 83.3% (p=0.066) of patients treated with a taxane alone.
For all these reasons, we rate it Not Satisfactory here.
The news release does not engage in disease mongering. It talks about how hair loss is a common side effect of chemotherapy and how minimizing side effects is considered important to overall treatment.
No funding sources are mentioned in the news release regarding the DigniCap clinical study. We find this problematic, since the makers of DigniCap collaborated with Target Health, a clinical research organization (CRO), to conduct the clinical trial and prepare the FDA application.
According to its website, Target Health is a privately held, New York City-based full-service contract research organization (CRO) committed to serving the pharmaceutical community with knowledge regarding regulatory affairs, clinical research, biostatistics, data management and Internet-based clinical trials.
As a result, we rate this Not Satisfactory.
The news release does not touch upon other hair loss therapies, including how they compare to the new cooling cap.
To treat hair loss doctors can recommend drugs, such as minoxidil (better known as Rogaine), which is an over-the-counter liquid or foam that patients can rub into their scalps to regrow hair and to prevent further hair loss. Physicians can also suggest hair transplant or restoration surgery to treat permanent hair loss.
In laser therapy, a low-level laser device is used to treat men and women with pattern baldness.
If patients don’t respond to the above treatments, they can try wearing hairpieces and wigs, whose costs may be covered by insurance. It’s also important to note that hair loss from chemotherapy is temporary for many women so more information about the duration of benefit may lead some women to conclude that short-term hair loss is an acceptable alternative.
It’s clear from the first sentence that the device is not yet available and that the FDA just approved the device for marketing to breast cancer patients.
DigniCap wrote on its website: “We will be finalizing agreements with major cancer centers and community oncology groups across the country so that they will be able to offer DigniCap® treatments to patients as soon as possible.”
The novelty of the medical device is established in the first sentence. The news release reports DigniCap is the first cooling cap cleared for marketing in the United States to reduce hair loss in female breast cancer patients undergoing chemotherapy.
Overall, the news release uses neutral, appropriate language and does not sensationalize the device.
The following phrase did raise a red flag, though. “The risk of the chemotherapy drug missing an isolated grouping of the breast cancer cells in the scalp because of the cold cap is extremely rare.” The small trial size and brief followup timeline don’t warrant such a definitive statement. It would have been more justifiable to state that this is a theoretical risk that is likely rare but conceivable based upon the purported action of the device.