Toward Zero Hair Loss for Breast Cancer Patients During Chemotherapy: Scalp Cooling for Alopecia Prevention (SCALP)
Can scalp cooling prevent hair loss during chemotherapy for breast cancer?
Memorial Hermann Memorial City Medical Center is one of six sites in the United States where physician researchers are investigating the safety and efficacy of the Paxman Orbis Hair Loss Prevention System in reducing chemotherapy induced alopecia in women with breast cancer who are undergoing neoadjuvant or adjuvant chemotherapy. If the U.S. randomized Phase III clinical trial shows outcomes similar to prior studies in Europe, Scandinavia, Australia and Japan, researchers are hopeful it will lead to FDA approval of the device.
More than 235 women will be enrolled in the American trial, which began in December 2013 and is expected to close by the end of 2016. “Most women who participate, whether they’re receiving the cooling cap or are in the control group, are delighted to be a part of this study,” says medical oncologist Frankie Ann Holmes, M.D. Dr. Holmes has focused her professional career on treatment and research into a cure of breast cancer.
“Many patients have commented that loss of hair ‘outs them’ as cancer patients, which they resent and consider an invasion of privacy. Yes, you can wear a wig, but having your own hair gives you a feeling of control at a time when you lose significant control over your day-to-day life.”
Frankie Ann Holmes, M.D.
Medical Oncologist affiliated with
Dr. Holmes joined the US Oncology Network and Breast Cancer Research Committee – and the medical staff of Memorial Hermann Memorial City – after 15 years of practice at The University of Texas MD Anderson Cancer Center.
Memorial City was selected as a study site through her research connections and collaboration with the Lester and Sue Smith Breast Center at Baylor College of Medicine, the trial’s sponsor.
“Dr. Holmes’ practice is at the core of a strong Memorial City-based breast cancer treatment group, with outstanding specialists in medical and surgical oncology and plastic and reconstructive surgery, as well as a strong multidisciplinary tumor board,” says Michelina Cairo, M.D., an affiliated medical oncologist who joined Dr. Holmes as a partner in November 2015 from Texas Oncology in the Texas Medical Center. “Our strong medical community and robust network of collaborators allows us to offer patients a very high level of care, which made Memorial Hermann Memorial City an appealing site for the trial.”
The Paxman scalp cooling cap and subsequent series of clinical trials grew out of the personal experience of Richard Paxman and his family.
“My mother had quite aggressive breast cancer at the age of 34, when I was 10,” says Paxman, who is managing director of the family-owned company. “At the time, her physicians offered scalp cooling as a potential way to prevent hair loss, but it failed to work. When her hair began to fall out, it was a visible sign of her illness that very much affected our family dynamics. Later, my father began investigating the technology with a real drive to do something better for patients going forward. We’re hoping the results of the U.S. trial will be in line with previous international results.”
Michelina Cairo, M.D.
Medical Oncologist affiliated
with Memorial Hermann
Trial participants wear the cooling cap 30 minutes before chemotherapy, during chemotherapy and 90 minutes afterward. They – and the physicians – know who is randomized to cooling versus the control group. A physician and a blinded observer examine every participant before each chemotherapy session.
“The trial adds a little more than an extra hour to the chemotherapy experience, but women who are participating recognize the benefits and tell us it’s worth the extra time,” Dr. Cairo says. “Those who are randomized to the control group know what a great service they’re providing to future breast cancer patients. They underscore the amazing generosity of patients who participate in clinical trials.”
“What’s exciting for us as physicians is the results we’re getting,” she adds. “To get through chemotherapy and feel good about yourself is very powerful. To the extent that they can, most woman want to continue to live their lives with cancer in the background to the general public.”
Dr. Holmes believes the trial also affirms the value of the human touch in caring for patients. “The success of the device relies heavily on ensuring that the cap is intimately attached to the scalp,” she says. “Richard came to Texas to make sure we were fitting the cap correctly to ensure the results would have little interference from fit deviations. If the device is successful, women undergoing treatment for breast cancer will be able to continue to live their lives as normally as possible with control over the information they share with the outside world.”
For more information about the trial, call 713.467.1722 or click here.