Cold Cap Therapy, or modern-day scalp cooling, involves the use of a special cap or set of caps, cooled to very cold temperatures, and worn for a period of hours before, during and after each chemotherapy treatment. It is believed that the cold temperature constricts the blood vessels leading to the hair follicles, reducing the amount of chemo drugs that reach the follicles during the period that the caps are worn; also, that the cold puts the follicles "to sleep," temporarily limiting their metabolic activity. (Of note, the drugs stay in the patient's system far longer, but reach the hair follicles when they are at somewhat diluted strength.) This process has been in use in Europe for over 20 years. Many thousands of patients in the United States have learned of and successfully used Cold Cap Therapy in the last few years.

According to editorials in the Journal of the American Medical Association (JAMA, February 2017), a majority of patients consider hair loss to be the most dreaded aspect of chemotherapy, and some fear losing their hair so much that they decide to forego chemotherapy entirely.

Addressing this concern, two Cold Cap Therapy solutions, the DigniCap^® and the Paxman Scalp Cooling System, which have both shown solid results in the fight against chemotherapy-induced alopecia, have now received FDA clearance.

These two JAMA editorials cite the clinical trials results for one or both of these systems (see Trials/Research subsection of this website for details), and both agree that there is sufficient evidence of the efficacy of these scalp cooling systems to warrant far more widespread usage. This is particularly compelling because the use of scalp cooling devices reduces or eliminates an extremely distressing side effect of chemotherapy.

The first editorial, “Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: The Time Has Come” by Dawn L. Hershman, M.D., MS, concludes, “Chemotherapy has been a mainstay of adjuvant therapy for breast cancer and has contributed to a reduction in breast cancer-related mortality. However, with the introduction of targeted therapies, it is appealing to imagine a future in which chemotherapy is no longer necessary and some of the distressing adverse effects of cancer treatments can be avoided. Until that time, identifying interventions, such as scalp cooling for the prevention of chemotherapy-induced alopecia, that reduce or eliminate treatment-associated toxic effects will help ease the distress associated with chemotherapy and may, as a result, improve outcomes for patients with cancer.”

In the second editorial, “Do the Data on Scalp Cooling for Patients with Breast Cancer Warrant Broad Adoption?” by Howard (Jack) West, M.D., West also focuses on the conclusions from one of the clinical trials.

West lauds the evidence showing that treatment now has the potential to render hair loss among cancer patients a less common occurrence and believes that frequent use and more research will continue to make Cold Caps more effective.

The Rapunzel Project couldn’t say it any better — “THE TIME HAS COME.”

The Oncology Nursing Society, in its Clinical Journal of Oncology Nursing, has also published articles supporting the use of Cold Cap technology.

The support of oncology nurses for the cold cap process is critically important. Nurses administer chemotherapy to patients, and they understand the anguish caused by hair loss. Two 2017 articles in the Clinical Journal of Oncology Nursing identify that hair loss is the most feared side effect of chemotherapy for as many as 75% of patients, and that cold caps, or scalp cooling, offers the best available option for mitigating this problem.

In "Scalp Cooling, a literature review of efficacy, safety, and tolerability for chemotherapy-induced alopecia" by Mikel Ross, BSN, RN, OCN, CBCN, and Erica Fischer-Cartlidge, MSN, CNS, CBCN, AOCNS, April 2017, the authors reviewed 40 years of studies and literature on the topic. They concluded "patients who use scalp cooling have better (hair) preservation than those who do not, despite variability in study design, populations, treatments, and outcome measure". They found tolerability high overall, and most importantly, that "the incidence of scalp metastases is low, and scalp cooling is unlikely to adversely affect their occurrence".

The authors concluded with some implications for practice, which we found extremely compelling.

• Encourage more use of scalp cooling to help reduce CIA, based on its overall positive effect, and because of the success it has had as a supportive care intervention in Europe and Canada and its increasing attention in the United States.
• Learn more about scalp cooling to help advance practice changes based on evidence by dispelling existing myths, providing evidence-based education, and advocating for universal access at a reasonable cost".

The second article, "Scalp Cooling, the prevention of chemotherapy-induced alopecia" by Anne Katz, PhD, RN, FAAN, August 2017, also reported on a review of the literature. She additionally addressed some of the practical considerations for oncology nursing, including time required to give patients hair care instructions, preparation time for treatment, and additional chair time needed for post infusion scalp cooling. The author concluded that "...using this procedure appears to afford some protection againt hair loss, albeit with increased nursing resources and chair time. Perhaps what this procedure offers with greater certainty is hope that hair loss can be prevented and, along with it, less distress and alterations in body image and quality of life for survivors."

We are thrilled to see editorial support for Cold Cap Therapy. The concept of "freezing the head" has been around since the 1970's. Technology and practice have finally evolved to a point where there are tangible benefits for solid tumor patients. All eligible patients should know there is an option that could allow them to save most of their hair during chemotherapy. In addition to awareness and accessibility, affordability must also be addressed as soon as possible.

There are two types of Cold Caps — machine capping systems and manual capping systems. Until 2016, only manual caps were available to American patients.

Two machine systems, DigniCap^® and Paxman, have now received FDA clearance. These systems are leased by hospitals and clinics and are only available where installed. See our Locations section.

The DigniCap^® system was cleared by the FDA in December 2015. The company, based in Sweden, has been installing systems in the U.S. since 2016. In July 2017, they received expanded FDA clearance - their system is now approved to treat both men and women with various solid tumor cancers (not just breast cancer). DigniCap has information on their website regarding medical insurance coverage for the use of their system. https://dignicap.com/insurance/

The Paxman Scalp Cooling System was cleared by the FDA in April 2017 and received their expanded FDA clearance in June 2018. Paxman, based in the UK, reports saving the hair of over 100,000 patients worldwide, and is now installing their system at numerous U.S. locations.

DigniCap^® — http://www.dignicap.com

Paxman Scalp Cooling System — http://www.paxmanscalpcooling.com Paxman also offers https://coldcap.com, a patient-centric website which can help patients decide if this process is for them, and which also offers support to patients along the journey, from treatment to hair care and more. 

Manual Cold Caps are not yet FDA-cleared, and generally can not be stocked by hospitals/clinics. They must be rented privately by patients and brought to chemo as personal property at this time. While the machines are becoming more available, manual caps are still the method by which most American patients save their hair.

A set of manual Cold Caps can be used at any location with the dry ice method. Patients acquire and freeze a number of caps, which are changed at specified intervals to maintain the proper level of cold. Some supportive chemo centers have biomedical freezers (see Locations section) so that dry ice is not needed.

We have vetted the following manual cap providers to the best of our ability and can recommend them based on feedback from patients, doctors and nurses. Please note that patients should always consult their physicians when considering Cold Cap Therapy and should request success data for their drug regimen as part of their inquiries with the cap suppliers.

Penguin Cold Caps were first used in the U.S. in 2005, and have been widely used here over the last decade. They have their own unique design and patented gel to hold temperature as long as possible. Penguin has over 20 years of data and experience and their caps are reported to work with almost all chemo drugs. Of note, in addition to very high success rates with taxanes like TC, they report their success rate may be as high as 70–80 percent with patients using AC. AC is usually toughest on the hair, and this appears to be a better outcome than any other type of cap at this time, to our knowledge.

Chemo Cold Caps began in 2012 after the co-founder saved her hair using Cold Caps. CCC uses an Elastogel cap with an outer insulated cover and a special four-point strap to ensure a snug fit. They provide caps, cooler and all needed supplies for each rental. Clients report their website and customer service are excellent. CCC data indicates a very high success rate with the taxanes. Inquire regarding other drugs.

Arctic Cold Caps started in 2015, again inspired by a family member who saved her hair using Cold Caps. Arctic also uses an Elastogel cap and provides caps, cooler and all needed supplies for each client. One-on-one training is available via Skype. Arctic has received a number of compliments from their users and the medical staff involved in their care regarding their successful outcomes and their customer service. They report excellent results with the taxanes and a number of other drugs. Please inquire for details.

Wishcaps began in 2013 after the founder assisted a close friend who saved her hair with Cold Caps. Wishcaps also uses Elastogel caps and provides renters with all needed supplies including cooler, digital timer and laser thermometer. Both patients and clinic staff confirm that Wishcaps offers outstanding customer service. Phone consultations are available to all clients. Wishcaps reports excellent results with the taxanes. Inquire regarding other drugs.

Warrior Caps was founded in July 2016 after founder Lisa completed 16 rounds of chemotherapy with the majority of her hair. The company uses a proprietary cap and provides everything needed for patients to have a successful capping experience. Newest to our list of recommended providers, Warrior has been called a "boutique company" based on the very personal care each of their "Warriors" receives. Warrior Caps have been used with high levels of success with even the toughest chemo regimens, including AC. 

Additional clinical trials of Cold Caps (both machine and manual) are expected to take place and will be posted here when they do.

Insurance Coverage for the process is discussed in our FAQ section. We are not the best source of insurance info (providers are) as we generally are not in contact with patients at the back end of chemo. Providers often know what codes have been successful, what insurers have been covering the process, and what paperwork is needed to file a claim. 

Financial assistance for patients using Cold Caps and Scalp Cooling Systems may be available.

Hair To Stay - National nonprofit

Patients with household incomes at or below 300% of the Federal Poverty Level (FPL) should go to www.hairtostay.org/apply-for-a-subsidy and fill out the form you will find there. (The FPL chart is available on their site to help you determine if you qualify to apply.) Note that HairToStay will not reimburse for expenses incurred before you are approved for assistance.

The Sue Paxman Fund for Mothers - National nonprofit

Funded by the Paxman Company and administered by Hair To Stay, this fund offers free Paxman Scalp Cooling to 2 ultra low income women per month. Patients must be mothers with children living at home, and whose household income is at or below 200% of the Federal Poverty Level. Contact HairtoStay.org to apply.

The Fleener Family Foundation - National nonprofit - Warrior Cap users only 

The Fleener Family Foundation (info@fleenerfamilyfoundation.org) works exclusively with Warrior Caps to ensure cold cap therapy is available to those in financial need. The Foundation has sole discretion on the application requirements and the distribution of caps based on criteria set by the Officers of the Foundation. US residents with household income at or below 300% of the federal poverty level are encouraged to apply.

Cold Capital Fund - District of Columbia, Maryland and Virginia residents only

Patients in the defined geography may contact coldcapitalfund@gmail.com to discuss possible assistance with the cost of renting cold caps or using scalp cooling machines at clinics.

Hope For Hair - North Carolina residents only

NC resident patients may go to hopeforhair.org/apply-for-a-subsidy for possible assistance with the cost of renting manual caps or using scalp cooling machines. Eligible patients will have household income at or below 400% of the Federal Poverty Level.

Cap and Conquer - Southeast Michigan residents only 

Patients in the defined geography may contact info@capandconquer.org to discuss possible assistance with the cost of renting cold caps or using scalp cooling machines at clinics.

Some hospitals and clinics have funding support available for patients using cold caps/scalp cooling machines at their facility. Be sure to inquire with your nurse or physician.

Manual cold caps can be used at any location with the dry ice method. However a biomedical freezer is of benefit to both patients and infusion centers. It saves patients/helpers the cost and effort of acquiring and handling dry ice, keeps all caps uniformly cold, and minimizes the number of helpers needed by the patient. Of note, both methods work equally well.

The cold cap process requires any freezer that can maintain a temperature of -30°C (-22°F). (Note that each cap has to be stored in its own box to ensure uniform temperature throughout.). Specifications for the freezer that The Rapunzel Project generally donates are as follow:

For a picture of this freezer, click here.

If your infusion center is interested in acquiring a donated biomedical freezer to support your cold cap users, please click here for further information.

1.  DRINK AS MUCH WATER AS POSSIBLE DURING CHEMO DAY. 

2.  Use only cool water in the shower.  

3.  Wash hair gently. Use a shampoo with pH similar to that of the hair in the 4.5 to 5.5 range, and no parabens or sulfates. Use clear shampoos, not "milky" or "creamy" ones. 

Sojourn’s line of hair care products has a pH of 4.5 - 5.5. They recommend their Color Preserve or Moisture Shampoo. 

L'Ange also has 2 appropriate products: Cascade Blowout Shampoo & Luxé Marula Oil Hydrating Shampoo.

4.  Do NOT use products that say volumizing, or that are opaque (rather than clear). Such products may coat the hair and keep oxygen from reaching the hair follicles.

5.  Use a detangling spray such as Kenra® Classic Daily Provision*(spray-on conditioner) or L'Ange's Réplenish Detangling Conditioning Spray or Extendé Leave-In Fortifying Detangler rather than a regular conditioner. Again this helps keep the hair follicles from being coated.

6.  Make the transition to these new hair care products as soon as possible before chemo starts, as it may take 2 weeks or more to fully clean old product residue off the hair.

7.  Coloring hair is not recommended until 3 months after chemo is finished, because the follicles still need time to recover from the trauma of chemo.

8.  Keep hair straight down during chemo; do not bunch or pile on top of your head.

9.  Be sure to change the hair part line with each session of chemo. It helps to protect the scalp.

10.  Hold hair when combing so as not to pull on the roots. Paxman recommends Tangle Teezer, the original detangling hairbrush, easily found online. Another flexible detangling brush that is easy on hair is the L'Ange Siena Flexi Vented Brush.

11.  Drying hair with a microfiber towel and sleeping on a silk/satin pillowcase are two ways to minimize damage and breakage to the hair. L’ange offers Microfiber Hair Wrap Towels and a Silk Collection.

12.  Do not use curling irons, electric rollers, or hot air hair dryers.

13.  Use adhesive-backed moleskin**, cut to the shape of the forehead, to protect skin when cold caps are on. If your hair doesn't cover your ears, use foam headphone covers to protect your ears.

14.  Have warm blankets, an electric blanket, or heating pads on hand to use, especially during and right after each cap change.

15.  Sit in a chair without a high back – otherwise working at the back of the head during cap changes is difficult.

16.  Use a travel-type neck pillow to support your head/neck during chemo.

17.  Find out if you can have lab work done the day before chemo, to shorten chemo day waiting time considerably.

18.  Find out if you can call in and request to have your chemo order sent up from the pharmacy before you leave home the morning of chemo – saving you up to an hour.

19.  Lucinda Ellery is a company that has a unique program for those with thinning hair (and even no hair). Read more at http://www.lucindaellery-hairloss.com/chemotherapy.php

20.  If you are looking for help camouflaging thinning hair, once all chemo treatments are finished, consider Nanogen Keratin Hair Fibers, which can be viewed here.

21. Chemo Hair and Skin is a line of beauty care products specially formulated for chemotherapy patients. 
https://chemohairandskin.com/

22. Paxman Scalp Cooling has a section on hair care and hair care products in their patient centered website. https://coldcap.com/hair-care/

*Click here to find a location in your area that carries Kenra Professional hair care products.

**Moleskin Plus is a Dr. Scholl’s product that can be found in any drug store. Purchase the padding roll so you can cut it to the size needed for your forehead

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.

• 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
• 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
• 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/

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.