Hello:  I'm trying to help my friend Janet (not her real name), who is
33 and has stage 3 ovarian cancer. She's gone thru major surgery,
followed by both chemotherapy and radiation, losing all her hair in
the process, which seriously compounded the trauma for her. She's just
learned that her recent "look-see" surgery shows some microscopic
particles of cancer in her abdomen. In a week they'll surgically
implant a port into her abdomen through which four chemo treatments
will be delivered, approximately one treatment monthly from September
through December. It's believed that this will vanquish the remaining
cancer, but she's told that she'll once again lose her hair, which has
only just begun growing in.  Janet learned that there is a
scalp-cooling technology which can prevent or diminish the
chemo-induced hair loss, but that her care provider (Kaiser)
apparently doesn't have it available.
     Obviously, we are all wishing that we could at least spare Janet
the pain of losing her hair all over again, especially since she's so
young, newly married, and has worked so hard to regain strength and
energy during her recovery (for example, she did a 30-mile bike ride
last weekend, and she swims and does yoga every day).  Another friend
of Janet's is a fully accredited, working RN, who is willing to donate
her time to learn and monitor the scalp-cooling machine -- assuming we
can find one to use!
   I've been searching, and mostly what I'm finding are machines that
are manufactured and used in London, the Netherlands, Israel . . .
everywhere but in California.  I've read about "Paxman coolers", the
SCSII, and the Penguin cold cap -- all overseas.
   I'm thinking that my emotional involvement with this issue is
messing up such limited research skills as I have, so I'm asking y'all
to figure out what kinds of "scalp cooling" or "hypothermia" machines
specifically designed to prevent/minimize hair loss in chemotherapy
patients are available in California (we're in Santa Clara), from what
manufacturers?  Can these machines be rented or leased, or must they
be purchased outright; if so, at what cost?  (If they have to be
bought, we're going to have to make some kind of major rush
fundraising effort, since Janet's port implant will be done on Sept. 2
and I believe the first chemo session will take place on Sept. 9.)
Will manufacturers rent/lease/sell to individuals (as stated above,
one of us is a California-licensed RN, which will hopefully add
credibility!), or only to hospitals? Or maybe there's a former cancer
patient out there who purchased such a machine and wants to resell it?
   I realize that this inquiry may sound a bit goofy, but the thing
is, these machines are clearly almost ridiculously easy to use (plug
it in, warm up ten minutes, put the cap on, shaping it to patient's
head size, and after fifteen minutes the drug can be delivered.
Depending upon the drug used, you leave the cap on somewhere between 2
- 3 hours following the drug's delivery. Alarm bells alert you if
something's gone awry, which is unlikely unless somebody tries to
unplug the thing.  And the effectiveness for this simple process is
very high -- many patients have no hair loss, some patients have some
hair loss, but nothing so major that they feel the need to wear a wig.
 Given all this, it seems so worth our while to try hard to find a way
to make the technology available for her.  I hope you researchers can
help!  Due to financial constraints of my own, I'm having to price my
question at $60, but I'd put it at the topmost level if I could!! 
Thanks very much for your work!

---

Request for Question Clarification by vitalmed-ga on 25 Aug 2003 06:58 PDT

Hello leslie22-ga,

I am researching this question for you and am reasonably confident
that we will find the product, particularly since you have some direct
knowledge about existing machines. The quest may be easier if you
could specify please the names of any manufacturers, brands, models or
vendors that you know of that exist for this type of equipment, even
if they are overseas. For example, do you have any identifying
information about the product or its manufacturers in Israel or
elsewhere?

Regards,

vitalmed-ga

Greetings Leslie22:

This is not a goofy inquiry at all and I applaud you for your kindness
and dedication to your friend's comfort.  However, it appears that
"cold cap" therapy is not FDA-approved:

From http://www.geocities.com/neesey2/story.html

"I was concerned about Desi losing her hair from chemo and discussed
this with my cousin, Gil. He told me of a co-worker who had undergone
chemotherapy and didn’t lose any of his hair because of a "cold cap."
Gil didn’t know the details but that’s all I needed to approach Dr.
Greffe with my request for one.

"Dr. Greffe explained that chemotherapy targets areas that are warm
and therefore, the cold cap prevented chemotherapy agents from going
to vital areas where cancer cells could be multiplying. He warned me
that although it could save her hair, there could be cancer cells in
the head area that we don’t know about and the cap would prevent them
from being killed by the chemo. He also warned me that this cold cap
had been ordered by the FDA not to be used by doctors until further
studies could be made."

**********

"11. What is a `cold cap' and do you recommend it to prevent hair loss
during chemotherapy?
A cold cap is a device that is placed over the patient's head during
chemotherapy to prevent hair loss. In general it's not very effective
and there has been some question about whether the chemotherapy is
being prevented from penetrating the area covered by the cap. There is
some recent data, however, to suggest that there may be some benefit
to using a cold cap to prevent Alopecia (hair loss) when using Taxol."
http://www.cancerlynx.com/breastfaq.html

*********

I located a contact at
http://www.clinicaltrials.gov/ct/show/NCT00062426?order=18 regarding a
cinical study that required "No concurrent cold cap alopecia
prevention" and one of the contacts was in California.  I phoned the
Cancer and Blood Institute of the Desert, Rancho Mirage, California,
and was told by a nurse there that the cold cap was no loner
FDA-approved because there was concern that the chemotherapy couldn't
reach the scalp.

Searching "scalp" and "cooling" at that site returned one result:
http://www.clinicaltrials.gov/ct/show/NCT00025987?order=1

However, the above is related to cooling the brain regarding seizures.

*********

I found the same info on the current Penguin Cold Cap at
http://www.tradepartnersuk-usa.com/products/xq/asp/SarticleType.6/Article_ID.887/qx/productsshow.htm
but it states they are looking for a US partner to assist with US
distribution.

*********

At http://www.esmo.org/reference/abstracts00/psc/705.htm there is the
temperature directive for a cold cap:

Scalp hypothermia of 15°C was maintained for 3 h using a crylon gel
filled cold cap, starting 15 min. before chemotherapy, which was
administered over 1.25 h. The alopecia preventing effect was
quantified using the WHO toxicity score from 0 - 4.

It may be that someone could make one for your friend but I would
advise speaking with the chemotherapy administrator before using it.

*********

Lastly, a refusal action from the FDA regarding the cold cap:

"United Kingdom                     XXX-0047393-5  1    1
    Medical Specialties of California
    London , GB                                             NOL-DO
    89I--ME   Cold Cap
                        11-AUG-2002                        NO 510(K)"

http://www.fda.gov/ora/oasis/8/ora_oasis_i_89.html

*********

I hope that another Researcher will be able to find you the cap in the
US and I suggest you speak with Janet's doctor about using it before
the procedure.  I wish I could have been of more help but perhaps the
information I located will be of some assistance.

My prayers are with your friend.

Best regards,
journalist-ga


SEARCH STRATEGY:

Hypothermia "regional scalp cooling"
hypothermia scalp treatment
"scalp hypothermia" therapy california
crylon gel filled cold cap california
gel filled cold cap california
FDA (searched "cold cap" in the FDA database}