Baby, It's Cold Outside, especially in Texas, where a clinical trial showed a new cooling cap system can prevent hair loss in cancer patients.

The ongoing trial involved 95 women with early stage breast cancer. After four cyles of chemotherapy, 48 of the patientsor 51 percentretained their hair. Meanwhile, 47 control patients had no hair after four rounds of chemotherapy. The results were so striking that researchers decided to stop the study early and report their findings at the San Antonio Breast Cancer Symposium last week. 

Chemotherapy works by rapidly dividing cells, which unfortunately includes the rapid division of hair cells, resulting in patient hair loss. Cool caps attempt to override this attack on the hair by lessening chemo's effects on hair follicles. Chemotherapy drugs travel through the bloodstream, so less blood flow to the scalp means less of the drug reaches vulnerable follicles. By chilling the scalp to about 66 degrees Fahrenheit, the caps constrict blood vessels and reduce blood flow by 20 to 40 percent, producing only mild effects, including headaches and discomfort. The women will be tracked over the next five years to monitor any cancer reoccurance. 

The study was funded by the manufacturer of the cold caps, Paxman Cooling, who is now seeking FDA clearance for their cold caps. Another brand of cold cap known as the DigniCap was cleared for use in the United States by the FDA in December 2015, according to the LA Times. 

cool cap medical device regulation case studyScalp-cooling technology has been used to treat solid tumor cancers, but shouldn't be used on patients with blood cancers because it consticts blood vessels. Researchers tested it on breast cancer patients because hair loss takes more of an emotional toll on women than men, according to the study leader Dr. Julie Rani Nangia of Baylor College of Medicine in Houston. 

Nearly 247,000 women have been diagnosed with breast cancer in the United States this year, according to the American Cancer Society. There are also about 2.8 million breast cancer survivors in the United States.

"When you lose your hair, everyone knows you're sick and looks at you differently," said Nangia. The cold cap could be an important option for women with breast cancer. If women don't have to lose their hair, it could help them personally and emotionally. 


To see more medical device industry news, subscribe to R&Q's Blog in the sidebar. To learn more about wearable techonolgy, check out this blog post! 

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!