Clinical Trials

Dignitana, a Swedish company, successfully completed first- and second-phase clinical trials of its DigniCap®. In December 2015 Dignitana received FDA (Food and Drug Administration) clearance to market the DigniCap System in the United States. And in July 2017 DigniCap received expanded FDA clearance - the system is now approved for men and women with solid tumor cancers (not just breast cancer). DigniCap machines are now being installed in US chemo centers. The DigniCap system involves circulating a very cold gel through a single tight-fitting cap, which is worn for the duration of the chemotherapy session, as well as for a period of time before and after chemo. For more information, go to www.dignitana.com.
Paxman, a British company, received FDA clearance for the Paxman Scalp Cooling System in April 2017, based on their multi-year randomized study. Their system also involves the circulation of a cold gel through a single tight-fitting cap. Paxman is currently installing their system in US chemo centers. http://paxmanscalpcooling.com/the-system/clinical-trials

The American doctors conducting the Dignitana trial published a paper in March 2011, reviewing cold cap data from over 4,000 patients. They concluded that scalp cooling does not pose a risk for scalp metastases. Read the report.


Research

Some of the more recent studies are listed below. Additionally there are links to the websites of the 3 leading cold cap manufacturers, where there is additional info.

From the Dignitana website 
https://www.dignicap.com/professionals

From the Paxman website 
https://paxmanscalpcooling.com/the-system/clinical-efficacy 

From the Penguin Cold Cap website 
http://penguincoldcaps.com/how-it-works/scalp-mets/


Scalp Cooling Bibliography

Also of note, a dedicated former user of Penguin Cold Caps has compiled an extensive bibliography of scalp cooling studies dating back to the 1970's. We have her permission to share this document, which can be found here.

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