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.

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.

• A new Penguin^™ cold cap study of 10 subjects found that 80% of early-stage breast cancer patients were able to save more than 50% of their hair. Read study results.
• The Rapunzel Project funded a study, conducted in 2020 via ASCO national survey, with the goal of better understanding oncologists’ support or lack of support for scalp cooling. View PDF or read the abstract.
• This study identifies significant gaps in physician awareness regarding the possibility of persistent chemotherapy induced alopecia PCIA (hair loss lasting beyond six months). View Results Here
• This study examines the frequency of persistent chemotherapy induced alopecia (PCIA) (about 10%) when patients take Taxotere (docetaxel) at relatively high dosages, and identifies that NO patients using cold caps incurred PCIA.
• Presented at the European Society for Medical Oncology (ESMO), this study tracked 158 women with breast cancer from early 2016 to early 2019 as they used a scalp cooling system to effectively prevent chemotherapy-induced hair loss. Read Study Results
• As seen at the December 2018 San Antonio Breast Cancer Symposium, four prominent physicians held a panel discussion on scalp cooling. Topics included: the importance of the process to patients, efficacy, safety and more. Watch the Video
• This ongoing study in Japan is examining the efficacy of the Paxman scalp cooling device among Asian women with breast cancer.
  POSTER AS PRESENTED AT SABCS 2018
• This Italian study found that the DigniCap scalp cooling device was effective in preventing alopecia in 86.2% of patients studied. They used a European anthracylcine formulation (different from that common in the US) followed by taxanes in sequential schedule.
  POSTER AS PRESENTED AT SABCS 2018
• This is a follow up study of the safety of the DigniCap scalp cooling system. No scalp metastases have been reported 3+ years following completion of study treatment.
  POSTER AS PRESENTED AT SABCS 2018
• A completed Japanese study of Asian patients using the Paxman scalp cooling device during chemotherapy infusion indicates that the system is as effective for hair loss mitigation in Asian women as Caucasian women.
  POSTER AS PRESENTED AT SABCS 2018
• New study finds that scalp cooling successfully prevents alopecia in breast cancer patients undergoing certain chemotherapy treatments. View PDF
• A study of scalp cooling efficacy, reviewing 330 cases from Brazil, concluded that scalp cooling appears to be effective in preventing CIA among breast cancer patients who had chemo; more psychological support and better pain management for patients using scalp cooling could increase adherence to treatment.
  POSTER AS PRESENTED AT SABCS 2017
• A study of 79 German patients utilizing scalp cooling showed success rates of 62.5% to 87% (depending on chemo drugs), with only a few headache/earache side effects which resolved quickly upon cessation of scalp cooling.
  POSTER AS PRESENTED AT SABCS 2017
• A study of Italian patients concluded that DigniCap appears to be an effective device in preventing CIA in a consistent proportion of patients undergoing chemotherapy and was well tolerated.
  POSTER AS PRESENTED AT SABCS 2017
• A study of 58 patients in Frankfurt, Germany concluded that DigniCap Scalp Cooling System has a minimal rate of adverse effects and reduces the likelihood of CIA effectively by 63%, even in anthracycline-based regimen.
  POSTER AS PRESENTED AT SABCS 2017
• This unique Voice of Cancer Patients study examined available online messages and discussion regarding CIA and scalp cooling devices. It concluded that despite significant discomfort, cost and inconvenience, many patients are satisfied with the use of scalp cooling devices for chemotherapy induced alopecia.
  POSTER AS PRESENTED AT SABCS 2017
• University of California San Francisco study assesses the overall effectiveness of the Penguin Cold Cap System on breast cancer patients undergoing chemotherapy. View PDF
• https://pubmed.ncbi.nlm.nih.gov/32959460/
• http://ascopubs.org/doi/full/10.1200/JOP.18.00033
• http://ascopubs.org/doi/10.1200/JOP.17.00038
• http://jamanetwork.com/journals/jama/article-abstract/2601503
• http://jamanetwork.com/journals/jama/article-abstract/2601500
• http://www.ascopost.com/News/44212
• http://www.ascopost.com/issues/april-25,-2015/scalp-cooling-caps-offer-option-to-prevent-hair-loss-during-chemotherapy.aspx
• http://www.ncbi.nlm.nih.gov/pubmed/25511368
• Analysis of two scalp cooling systems assesses tolerability and efficacy of both options for treatment of alopecia. View PDF
• http://meetinglibrary.asco.org/content/115276-132
• http://meetinglibrary.asco.org/content/85116-102
• http://meetinglibrary.asco.org/content/40393-74
• http://cancerres.aacrjournals.org/cgi/content/meeting_abstract/72/24_MeetingAbstracts/P2-12-12?sid=34ae2193-a655-4945-9eb9-eb33746f23f1
• http://www.royalmarsden.nhs.uk/SiteCollectionDocuments/education-conference-centre/events/2012-advances-scalp-cooling/hope-rugo.pdf
• http://news.cision.com/se/dignitana-ab/r/researchers-gather-at-the-royal-marsden,c9310526
• http://www.journalnow.com/news/local/article_98a8da24e75d-11e2-9987-001a4bcf6878.html
• http://bigstory.ap.org/article/cold-caps-tested-prevent-hair-loss-during-chemo
• PBS on Hope Rugo and Dignitana - See 3rd segment.

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/

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.