While nothing easy or simple comes from a cancer diagnosis, one of the most traumatic experiences for breast cancer patients, particularly for women, is hair loss. Dr. Julie Nangia, assistant professor in the Lester and Sue Smith Breast Center within the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, sees this all too frequently when treating her patients.
“Hair loss takes a tremendous toll on the patient’s body image, and they no longer have the anonymity of hiding the disease; everyone can see that they’re sick,” said Nangia. “Patients and physicians have been hoping and searching for methods or therapies to prevent or reduce hair loss due to chemotherapy, but the options have been very limited due to the complexity of both the disease and the treatment.”
Nangia may have found the answer in research presented at the 2016 San Antonio Breast Cancer Symposium, which details the results of a study using a scalp cooling cap to reduce hair loss in breast cancer patients undergoing taxane or anthracycline chemotherapy.
The Orbis Paxman Hair Loss Prevention System, a product of Paxman Coolers Ltd., consists of a two-cap system, with the inner silicon cap circulating a refrigerated fluid and the outer neoprene cap insulating the scalp and fitting snugly to the patient’s head with a chin strap. Both caps are fitted once and worn for the duration of each chemotherapy treatment. The two-cap system ensures the coolant stays at a consistent temperature, and is connected to a small machine, which can be briefly detached from the patient to allow for greater mobility during sessions.
The study involved seven trial sites across the country, and enrolled 182 women with either stage I or II breast cancer who planned to have at least four cycles of either taxane or anthracycline-based chemotherapy. Study participants were randomized on a two to one ratio to determine if they received the scalp cooling device versus no cooling therapy.
The primary objective of the trial was to determine the safety and efficacy of the scalp cooling device in reducing hair loss in patients undergoing chemotherapy.
During treatment, the patients who received scalp cooling wore the device for 30 minutes prior to their chemotherapy treatment, for the duration of their treatment and for 90 minutes following treatment.
“Chemotherapy treatment works by attacking rapidly dividing cells, but in doing this, it also targets rapidly-dividing hair cells, 90 percent of which are in the growth stage, resulting in hair loss,” said Nangia. “With scalp cooling, we are lowering the temperature of the scalp, thereby constricting the blood vessels and reducing the flow of blood to the hair follicles, which will help reduce hair loss by limiting the amount of chemo drugs reaching the follicles.”
At the time of provisional analysis, 95 patients in the cooling group and 47 patients in the no cooling group were evaluable and had completed four cycles of chemotherapy. Among them, 48 (50.5 percent) out of 95 in the cooling group had hair preservation, compared to zero out of 47 in the no cooling group.
At a 50 percent success, the trial’s results crossed the superiority boundary and resulted in researchers ceasing to accrue patients and halting the study early to release the data.
Throughout the trial, mild side effects such as headaches and temporary discomfort were reported. Patients involved in the scalp cooling study will be followed for five years to determine any adverse effects.
“Variation in hair retention across the sites is likely a result of different types of chemotherapy administered – taxanes have higher hair retention rates – and the learning curve for fitting and operating the scalp cooling cap by nurses and physicians,” explained Nangia. “As the cap becomes more widely-used, best practices will be developed to ensure maximum results.”
The trial shows that scalp cooling using the Orbis Paxman Hair Loss Prevention System is effective in hair preservation and should become available for patients who receive chemotherapy for early-stage breast cancer.
“We chose to focus this study on women with breast cancer because of its prevalence and large patient population, and women are more emotionally sensitive to hair loss in general,” said Nangia. “Preventing hair loss may help improve the emotional well-being for patients and help them maintain a degree of privacy.”
Paxman will be filing for FDA clearance for its device.
The study was funded by Paxman Coolers Ltd. Other trial sites include Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Texas Oncology Baylor Sammons Cancer Center, Texas Oncology Medical City Dallas, Texas Oncology Memorial City and Hematology and Oncology Associates of Northern New Jersey, now Summit Medical Group-MD Anderson Cancer Center. Nangia declares no direct conflicts of interest, but Paxman Ltd provided financial support to her institution for the clinical trial.
Other contributors to this study include Tao Wang, Polly Niravath, Mari Rude, Susan Hilsenbeck, C. Kent Osborne, Mothaffar Rimawi and Kristen Otte, all with Baylor College of Medicine, Cynthia Osborne, Frankie Holmes and Jay Courtright with Texas Oncology, US Oncology, Richard Paxman with Paxman Coolers Ltd., Steven Papish with Summit Medical Group-MD Anderson Cancer Center, Jame Abraham with Cleveland Clinic and Mario Lacouture with Memorial Sloan Kettering Cancer Center.