FDA Clears Cold Cap to Save Hair During Breast Cancer Chemo
By THE ASSOCIATED PRESS

WASHINGTON — Hair loss is one of the most despised side effects of chemotherapy, and now breast cancer patients are getting a new way to try to save their locks.

The Food and Drug Administration said Tuesday it would allow marketing of the DigniCap, a cooling system that chills patients' scalps to reduce the hair loss that is so common during breast cancer treatment.

A doctor who led research with the hair-preserving strategy welcomed the FDA's move, saying hair loss has a traumatic effect on patients, and survivors, by revealing an illness that many would prefer to keep private.

"It's such a marker for women — for work, for their families, for their children — that something's wrong with them," said Dr. Hope Rugo of the University of California, San Francisco. "You get just a few months of chemotherapy, and it takes more than a year for your hair to recover."

Scalp cooling is an idea that's been around for decades. The near-freezing temperatures are supposed to make it harder for cancer-fighting drugs to reach and harm hair follicles by temporarily reducing blood flow and cell metabolism in the scalp.

Several versions of cold caps are sold around the world. In the U.S., breast cancer patients sometimes bring collections of gel-filled caps to chemo sessions in ice chests, or store them in hospital-provided freezers, so that when one cap thaws they can don another.

But the DigniCap, made by Sweden's Dignitana AB, is the first version officially cleared by the FDA. The company will lease the device to cancer centers to use as their patients come in for chemotherapy.

How it works: A half-hour before starting a chemo session, patients strap on a tight-fitting cap that's connected to the cooling machine. It gradually chills the scalp, being careful to stay above freezing, until it's numb as the chemo infusion begins. Patients stay hooked to the cooling system during the treatment, and for about an hour and a half later as blood levels of the cancer-fighting drugs drop.

Rugo and oncologists at four other medical centers studied the DigniCap system in 122 women undergoing standard chemo regimens for early-stage breast cancer. More than two-thirds of the treated women kept more than half their hair.

"Looking healthy made me feel healthier," said Deanna King of San Francisco, who participated in the trial in late 2013 and said she retained 80 percent of her hair.

She'd been between jobs when she was diagnosed with breast cancer, and keeping her hair made it easier to restart interviews with potential employers as soon as she felt well enough.

"People are frightened of people that look sick," King said. "It made the experience a little less traumatic."

The most common side effects of the DigniCap treatment were cold-induced headaches and neck and shoulder discomfort, chills and pain associated with wearing the cooling cap for an extended period, the FDA said.

Some doctors had long wondered if the cold could prevent chemotherapy from reaching any stray cancer cells lurking in the scalp. The FDA said the risk of that happening "is extremely rare."

"Because women tend to survive early breast cancer for so many years, the FDA should provide the evidence to show if there's any long-term risk," said Dr. Len Lichtenfeld of the American Cancer Society. He said women should discuss the option with their doctors.

The cost is still being finalized but patients would be charged a fee for each DigniCap use. Depending on how many rounds of chemo a woman undergoes, the total cost could range from $1,500 to $3,000, said Dignitana chief operating officer Bill Cronin. The company is negotiating with insurance companies for coverage.

「尊嚴帽」冷卻頭皮 為化療者減掉髮之痛

乳癌患者接受化療，掉頭髮是令她們最難過的治療副作用之一，有好幾款減少化療乳癌患者掉髮的系統已在國際間流傳，但瑞典Dignitana AB公司出品的DigniCap系統8日獲得美國食品藥物管理局（FDA）批准上市，成為唯一獲得入美的這類系統。

舊金山加州大學乳瘤與臨床試驗教育中心主任魯戈說，有用的化學療法仍然導至患者頭髮掉光，造成許多女性情緒極大傷害，該中心與Dignitana合作，試用以冷卻頭皮為主要原理的DigniCap（直譯「尊嚴帽」），證明安全又有效，如今這套系統獲FDA批准，許多患者將大大減少掉髮之痛。

美國106位試用者，只有三人耐不住寒冷而放棄，試用者對自己的決定（參加試用），滿意度達87.5，對保住的髮量，滿意度70.9%。對保住的頭髮的品質，滿意度69.1；而初期癌症患者試用，約有七成至少保住50%頭髮，且無明顯副作用。

這套系統即將進入全美的相關治療中心，美國的試用裡，化療者療程使用的化學藥物主要是汰癌勝（taxene），包括注射液「太平洋紫衫醇」（paclitaxel，又稱「派立達師」），與「歐洲紫杉醇」（docetaxel，又稱「克癌易」）。

美國以外地區試用DigniCap者，其療程使用的化學藥物主要是小紅莓類（anthracycline），例如速溶泛艾黴素（epirubicin）與阿黴素（doxorubicin）。

DigniCap的結構是一款專利矽利康材質的冷卻帽，直接套在頭上，外罩一層氯丁橡膠帽，使矽利康帽絕緣且穩固，內建感應器，可監控頭皮接受的冷卻溫度絕不降到冰點（華氏32度、攝氏零度）以下，冷卻效果可散布於整個頭皮。

頭皮冷卻，導至頭皮血流量降低，使進入頭皮的化學藥物減少，毛囊吸收的藥量也降低。這些因素共同降低掉髮機率。

原文參照：
http://www.nytimes.com/aponline/2015/12/08/health/ap-us-med-chemo-caps.html

2015-12-09．聯合晚報．A7．健康．編譯彭淮棟