BACKGROUND: The chemo cold cap is soft, elastic, covered by a thermo insulate that is used to cool the scalps metabolism and blood flow, to protect the hair follicles from chemo drugs. Hair loss is an inevitable side effect of chemotherapy and it is not a medical issue. Hair loss occurs because chemotherapy targets all rapidly diving cells, healthy cells as well as cancer. Hair follicles, the structures in the skin filled with tiny blood vessels that make hair, are some of the fastest-growing cells in the body. When healthy, hair follicles divide every 23 to 72 hours, but as the chemo does its work against cancer cells, it also destroys hair cells. Within a few weeks of starting chemo, patients may lose some or all of their hair. Drug induced alopecia occurs in over 80 percent of patients and represents a major psychological fall back for patients. The cold cap treatments have been successfully used in Europe, New Zealand the United Kingdom for years. Now backed by clinical studies the U.S is beginning to look at cold caps for hair retention.
(www.breastcancer.org) ; (www.advancecoldcap.com)
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EFFICACY: In a clinical trial that involved 98 patients, 93 females and 5 males, divided into metastatic breast cancer, advanced ovarian cancer and advanced pancreatic cancer; the cap was placed as a tightly as possibly by applying a wet single-use mobcap on the patient's hair. The temperature of the cap had to be around 13 degrees Fahrenheit. Adherence to the scalp was improved by bandages. Cotton protected the nap, brows and ears. Chemotherapy was started 15 minutes after putting the cap on; the cap was changed 30 minutes after the beginning of the infusion, and the second cap was worn for one hour. Alopecia was assessed according to the World Health Organization. Success was defined as WHO grade less than or equal to two alopecia and no need to wear a wig, according to patient's decision. Failure was defined as the fact that the patient wore a wig whatever the grade of alopecia.
All patients but one was evaluable for the results, because they refused chemotherapy. Of the patients, 83 were successful responders to the cap as they had a WHO grade zero or grade one alopecia. Only 14 patients were evaluated as a failure because seven of them refused to continue with the cold cap, and the other seven had to wear a wig.
The conclusion was the cold cap is an effective technique for the prevention of Docetaxel-induced alopecia.
(European Journal of Cancer, 1997)
APPLICATION: Most doctors are willing to use the cold cap treatment, however there are many who have not heard of the treatment and will need research and clinical information.
There is a service now offering cold caps, however insurance does not cover the cost. Through Advance Cold Cap Services, patients can order their cold caps that arrives in a cooler that is packed with dry ice in special compartments that allows effective cooling. The dry ice is not accessible to the user, so they never have to handle it or touch it. Six cryogel caps arrive frozen and easy to access. The cooler remains at a temperature at or below -50 degrees Fahrenheit and can do so for up to 5 days. They can be refrozen and cycled for repeated applications during treatment. The cost for the treatment is $249.
Dr. Susan Melin, Medical Oncologist at Wake Forest Baptist Medical Center talks about a revolutionary breakthrough for chemo patients.
So with cancer, you see obviously a lot of cancer patients, you were telling me before and if you give me this as a complete thought, what are the patients wanting to know when they come to you tell them they're going to undergo chemotherapy?
Dr. Susan Melin: I think one of the first questions the patients ask when you recommend chemotherapy is "Am I going to lose my hair or not?".
What have you had to tell them in the past?
Dr. Susan Melin: Well the most common types of chemotherapy that we use, particularly in treatment of breast cancer, do cause chemotherapy induced hair loss to the point that they'll lose the majority of their hair, if not all of it, and then need to wear either a head garment or wig.
Does that kind of add insult to injury for somebody who's already dealing with a cancer diagnosis?
Dr. Susan Melin: Absolutely, I think on two different fronts. One is, it affects your body image and secondly, going bald is a declaration to the world that you're undergoing chemotherapy and you're a cancer patient.
What's this new thing and why is it such a big deal?
Dr. Susan Melin: The Dignicap, which is a machine that cools the scalp while you are undergoing chemotherapy helps preserve the hair. It cools the scalp down and by doing that prevents the chemotherapy from actually getting into the hair follicles and causing hair loss. It's been very well received, it's been very effective, and it's been very well tolerated.
What have you seen in your patients in terms of the impact this had had?
Dr. Susan Melin: The patients that I've treated that have undergone this Dignicap have been delighted by the fact that they preserve the majority of their hair, and therefore, they've been able to get by without having to wear a wig or a head piece.
This technology it's obviously new in the United States, but there's other places where it's already available?
Dr. Susan Melin: This Dignicap was developed in Sweden, and this Swedish company has had studies in Europe, in Asia, and of course in Scandanavia.
In terms of how soon this could be available, do you have any sense or any hope of how soon this could be available for you to offer it to your patients, because it's like everything else-you can offer it to the patient, if they don't want it they don't have to take it.
Dr. Susan Melin: Right, we have just completed accrual, meaning we've gotten all the patients we need for a feasability study that the FDA required that we do, and then once we've gotten approval by them we will then move to the next phase which is a pivotal study that will enroll 100 patients total. Hopefully by then we'll get approval by the FDA to use this machine in a variety of different types of cancer with different chemotherapy regiments.
As a doctor, why would this be a nice thing to have?
Dr. Susan Melin: Going through chemotherapy for cancer is very traumatic for people on several different levels, and I think if you can preserve their dignity, if you can help preserve their appearance then it adds to their quality of life.
Are there any side effects or potential side effects to this thing or is there anything that you've seen that could be a potential down side to this?
Dr. Susan Melin: Two things;,, one is using the actual machine it cools your scalp and so patients do get cold, so we tell them when they come in for chemotherapy to please dress yourself warmly and we provide blankets etc. Some patients do get a mild headache with it but that usually resolves as soon as they're done with the chemotherapy session. The one issue that the FDA has been concerned about is this type of technique was tried way back in the 1970's when we did chemotherapy for patients who had different types of cancer, cancers that involved blood cells; and the concern was that if you had circulating cancer cells that maybe were in the scalp that they would be spared when you got chemotherapy, so the concern of recurrent cancer that's isolated to the scalp. That's been recorded exactly twice in breast cancer patients.
And that's probably part of the reason these are phase I patients?
Dr. Susan Melin: Part of the reason why they're (FDA) making us do both the feasability study as well as this pivotal study because they'll be following patients along. Now the studies that have already been completed in Europe, Scandanavia and Asia, they're of course following those patients but the incidents of scalp metathesis as the first recurrence is exceedingly low.
So you're feeling pretty good about this thing…
Dr. Susan Melin: Feeling very good about it.
FOR MORE INFORMATION, PLEASE CONTACT:
Bonnie Davis
National Media Relations Manager
Wake Forest Baptist Medical Center
(336) 716-4977
bdavis@wakehealth.edu