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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 dignicap.com/research.

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. https://paxmanscalpcooling.com/research/

Regarding the risk of a primary metastasis to the scalp, all indications are that this is extremely unlikely.
In a 2015 publication, Dr. Hope Rugo stated “We understand a lot more about the biology of cancer and metastatic disease now; it turns out that the risk of metastases to the scalp is extremely low, and as a first event for advanced disease, it is even lower. Mostly, scalp metastases are seen after people have already had metastases to other places in the body, and in total, only about 1.2% of all metastases are found in the scalp.”
Dr. Rugo continued, “… [scalp metastasis] would have to be the first site of metastatic disease to postulate that it has anything to do with scalp cooling, and that is very uncommon in the studies that are available. I’ve reviewed over 4,000 patients reported in clinical trials, and it is just exceedingly rare and doesn’t seem to be any higher in risk, from what we can tell, in patients who are using the cold cap.”

A 2017 publication provides further support for this conclusion. 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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