Frozen Glove Reduces Skin and Nail Damage from Docetaxel Chemotherapy
Patients who wore an experimental “frozen glove” to keep their hands very cold during intravenous chemotherapy with docetaxel (Taxotere®) had much less subsequent damage to the nails and skin of their hands, according to a French study.
Docetaxel belongs to the taxane class of chemotherapy drugs. Taxanes stop cancer cells from reproducing and have been effective in a wide range of cancers. About half of those taking docetaxel experience a side effect known as “hand-foot syndrome,” the symptoms of which can range from relatively mild tingling and numbness to painful peeling and blistering of the skin.
Nail problems are another potential side effect of docetaxel. In about 40 percent of patients the nails become brittle or discolored; in about 3 percent, nails may even become infected and begin to fall off (onycholysis).
While in many cases these effects may be only cosmetic, at times they can cause pain to the point where patients may quit or interrupt treatment. Docetaxel is approved by the U.S. Food and Drug Administration for the treatment of numerous cancers including breast, lung, and prostate, and thus many thousands of patients are at risk for these side effects every year.
Cold treatments (cryotherapy) of the scalp have been used to reduce hair loss after chemotherapy. It is not known precisely how the cold prevents chemotherapy damage to the nails and skin, but some studies suggest that lower temperatures reduce the amount of the drug that reaches these tissues.
In this multicenter, phase II study, researchers in France enrolled 45 patients during 2002-03 who were scheduled to receive docetaxel for a variety of different types of cancer. None of the patients had received taxane treatments prior to entering this study and all were free of nail and skin problems on their hands.
On their right hand, all patients wore an Elasto-Gel flexible glove (made by Akromed, a French company), which covers the hand like a mitten – fingers together, thumb separate. Glycerin in the glove retains the cold captured by refrigeration. The gloves were refrigerated for at least three hours at about minus-30 degrees Celsius (minus-22 degrees Fahrenheit).
Patients wore the frozen glove for a total of 90 minutes, 15 minutes before and 15 minutes after a one-hour intravenous infusion of docetaxel.
Halfway through treatment (45 minutes), patients were fitted with a new glove so the level of cold would be sustained. Changes to the nails and skin on the cold hands were compared to the patients’ left hands, which had not been protected by the glove.
The study was led by Florian Scotté at the Georges Pompidou European Hospital in Paris.
The patients’ hands that were protected by the frozen glove had fewer problems with their skin and nails than did their unprotected hands; these problems were also less severe. Nail problems were non-existent in 89 percent of the gloved hands, compared to 49 percent of the unprotected hands.
Onycholysis, where the nails separated from the fingers, occurred in none of the protected hands while afflicting 22 percent of the unprotected hands. All of these results were statistically significant.
Fully two-thirds (67 percent) of the gloved hands were free of skin problems. Minor skin problems occurred in 44 percent of the unprotected hands, but in only 22 percent of the gloved hands. Serious skin problems occurred in 9 percent of the unprotected hands and 2 percent of the gloved hands.
Again, these results were statistically significant.
The researchers asked patients about how well they were able to tolerate the coldness and constraints of the glove, along with other “comfort” factors. Of the 43 patients who responded, 37 (86 percent) said they were satisfied with the treatment, while six were not. Five of those withdrew from the study.
Supportive care clinical trials like this one often focus on the side effects from chemotherapy and other treatments, testing interventions that may improve the quality of life for cancer patients.
The study “was extremely straightforward and the results very striking,” said Ann O’Mara, Ph.D., R.N., of the National Cancer Institute’s Community Clinical Oncology Program, “and builds on a foundation of work using cold treatments to prevent alopecia (loss of hair). This is very encouraging, and I would expect larger trials to follow.”
While the frozen glove was more effective in protecting nails than skin, “it is the hand-foot syndrome and skin problems that are often much more painful in the clinic,” said O’Mara. Patients can lose the skin protecting their palms, become significantly incapacitated, and experience considerable pain for weeks or even months after the three-week treatment.
O’Mara also said that asking patients if they were satisfied with the comfort of the glove may have missed more meaningful measures of comfort. Pain and function are both significant aspects of the patient’s experience, she said, “that go well beyond the limited measure of satisfaction” as described here.
Some researchers have voiced concern that cooling skin cells might keep chemotherapy from ridding them of cancer or may alter the metabolism of the chemotherapy in the cells.
However, this concern probably doesn’t apply to the frozen glove treatment, said O’Mara, given that cutaneous metastases (the spread of cancer from the original tumor to the skin) are unlikely near the hands.
Journal of Clinical Oncology, July 1, 2005 Our Source: NCI
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