What is Cold Cap Therapy?

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.


Recent editorials in the Journal of the American Medical Association support the use of Cold Caps.

According to recent editorials in the Journal of the American Medical Association (JAMA, February 2017), approximately 50 percent 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.

In these two JAMA editorials citing the clinical trials results for one or both of these systems (see Trials/Research subsection of this website for details), both editorials 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 for patients.

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.”

We are thrilled to see editorial support for Cold Cap Therapy. Every eligible patient 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.


The Caps

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. 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

 

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 Elastogel caps 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. Please inquire for results with various drug regimens.

 

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

 

Financial assistance for patients using Cold Caps may be available. Patients with household incomes at or below 300 percent 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 Freezers

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:

Model Number 34-09CCF, white chest style freezer
42” long x 24” deep x 35” high
140 pounds (210 pounds crated), on casters
Holds 28 cold caps in individual storage boxes (2 patients/day)Freezes to -34°C
8 amps, 115 volts
Quiet operation
Thermostatically controlled.
Lid lock with two keys provided
 

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.


Tips for Cap Users

1.  Use only cool water in shower 

2.  Wash hair gently 

3.  Use a gentle shampoo with pH similar to that of the hair in the 4.5 to 5.5 range. Use clear shampoos, not "milky" or "creamy" ones. The Director of R & D at our partner, Kenra, advises that Kenra® Clarifying Shampoo* meets these requirements. Googling shampoos with 4.5-5.5 pH will help you find other products that should be appropriate.

4.  Do NOT use products that say moisturizing or 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) 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.  Don’t pull on the roots

10.  Hold hair when combing so not to strain the roots

11. Sleep on a satin pillow case

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

13.  DRINK AS MUCH WATER AS POSSIBLE DURING CHEMO DAY

14.  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

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

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

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

18.  Find out if you can have lab work done the day before chemo, because this shortens chemo day waiting time considerably

19.  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

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

21.  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

22.  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.

 

*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


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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