More than half of women with stage I or stage II breast cancer who underwent scalp cooling while receiving chemotherapy retained their hair during treatments with minimal adverse events, according to a pair of studies published in JAMA.
“Scalp cooling is relatively new to the United States market, but Paxman Coolers first launched their device in the United Kingdom in 1997,” Julie Nangia, MD, assistant professor of medicine at Lester and Sue Smith Breast Center of Baylor College of Medicine, told HemOnc Today. “A study from Dignitana was published last year in the United States using similar scalp-cooling technology, although that trial was not randomized, and research continues to be conducted.”
Hope S. Rugo
Because rapidly growing cells, such as cancer, and hair follicles are more susceptible to chemotherapy, many women experience hair loss (alopecia) during treatments. Women often rate hair loss as one of the most distressing adverse effects of chemotherapy.
Scalp cooling reduces blood flow to hair follicles and, therefore, reduces biochemical activity. It is achieved by wearing a cooling cap that circulates refrigerated liquid.
Nangia and colleagues evaluated the Orbis Paxman Hair Loss Prevention System (Paxman) — which is currently not approved by the FDA or reimbursed by health insurance. The cap is connected to a cooling system, placed on a patient prior to chemotherapy, and does not have to be changed or removed until the treatment is completed.
In another study, published simultaneously, Hope S. Rugo, MD, clinical professor of medicine and director of the Breast Oncology Clinical Trials Program at UCSF Helen Diller Family Comprehensive Cancer Center, and colleagues evaluated the DigniCap (Dignitana AB) cooling device, which was cleared by the FDA in 2015.
Nangia and colleagues randomly assigned 182 women (mean age, 52.1 years; 83% white) from seven different sites in the United States to scalp cooling (n = 119) or the control arm (n = 63). The primary endpoint was successful hair preservation, defined using the Common Terminology Criteria for Adverse Events scale as no hair loss or less than 50% hair loss. Secondary endpoints included wig use, quality of life, anxiety and body image.
In total, 95 women in the scalp-cooling arm and 47 in the control arm completed the first chemotherapy cycle and were evaluable for alopecia (n = 142). Sixty-four percent (n = 91) received taxane-based chemotherapy and 36% (n = 51) received anthracycline-based chemotherapy.
Researchers observed successful hair preservation in 48 women who received scalp cooling (50.5%, 95% CI, 40.7-60.4) compared with no women in the control group (0%, 95% CI, 0-7.6; success rate difference, 50.5%; 95% CI, 40.5-60.6). The 1-tailed P value from the Fisher exact test was < .001, which crossed the superiority boundary of .0061. Thus, the data and safety monitoring board recommended the study be closed early.
Sixteen percent (95% CI, 4-46) of women in the scalp-cooling arm who received anthracycline-based chemotherapy reported hair preservation compared with 59% (95% CI, 27-84) of women treated with taxanes.
Wigs or head wraps were used by 63% (95% CI, 53-72) of the patients who received scalp cooling and 100% (95% CI, 92.4-100) of the control group. There were no statistically significant differences in quality of life from baseline to chemotherapy cycle 4 among the scalp-cooling and control groups.
A total of 54 adverse events occurred in the scalp-cooling group. All adverse events reported were grade 1 (n = 46) or grade 2 (n = 8) and included chills, dizziness, headache, nausea, paresthesia, pruritus, sinus pain, skin and subcutaneous tissue disorders, and skin ulceration.
“There were no serious adverse events,” Nangia said. “Overall, patients rated the device as reasonably comfortable.”
Four women withdrew from the study because the cooling device was too cold or uncomfortable, one due to claustrophobia, and one due to anxiety. Sixty additional participants were enrolled in the trial, and the last participant was expected to complete chemotherapy in February 2017.
Quality of life
In another study, Rugo and colleagues randomly assigned 122 women (mean age, 53 years; 77% white) to scalp-cooling (n = 106) or control (n = 16) groups.
Patients were fitted with DigniCap and scalp cooling was initiated 30 minutes prior to the chemotherapy cycle, with scalp temperature maintained at 37 degrees throughout chemotherapy and for 90 and 120 minutes afterward.
Average duration of chemotherapy was 2.3 months. Researchers conducted follow-up at 4 weeks after the last dose of chemotherapy, and median follow-up was 29.5 months.
Researchers considered treatment success a dean scale score of 0 to 2, or 50% or less hair loss. They also evaluated quality of life at baseline, at the start of the last chemotherapy cycle, and 1 month later.
No women in the scalp-cooling group received anthracyclines.
Hair loss of 50% or less occurred in 67 patients (66%; 95% CI, 56.2-75.4) in the scalp-cooling group and no patients in the control group (P < .001).
Three of five quality-of-life measures were significantly better 1 month after the end of chemotherapy in the scalp-cooling group. Of patients who underwent scalp cooling, 27.3% (95% CI, 18.0-36.6) reported feeling less physically attractive compared with 56.3% (95% CI, 31.9-80.6) of patients in the control group (P = 0.02). A small proportion of women in the scalp-cooling group reporting being dissatisfied with their body (15.9% vs. 37.5%; P = .04) or upset about loss of hair (32.4% vs. 60%; P = .04).
Four women in the scalp-cooling group experienced mild headaches and three discontinued use due to feeling cold.
Although the results of the two studies are promising, scalp-cooling caps will need to be fitted properly to maximize effectiveness and gain FDA approval, Nangia said.
“Additional research will be conducted to determine any long-term adverse events and any increased risk for scalp metastases,” Nangia said. “We would also like to research the efficacy in stage III breast cancer and other solid tumors. Better quality-of-life tools need to be developed to evaluate the full impact of chemotherapy-induced alopecia on the psyche.”
Approximately 50% of women with breast cancer consider hair loss the most traumatic aspect of chemotherapy, and about 8% report they would decline chemotherapy because of its associated alopecia, Dawn L. Hershman, MD, MS, associate professor of medicine at Columbia University Medical Center, wrote in an accompanying editorial.
Currently, the average total cost of scalp cooling is estimated to range between $1,500 and $3,000 per patient, depending on the number of treatment cycles.
The quality-of-life findings in both studies lacked specificity and should be interpreted with caution, Hershman wrote, adding that temporary hair loss can be perceived as cosmetic and, as a result, gaining FDA approval for a scalp-cooling device could prove challenging.
“Similar arguments could be made for breast reconstruction following mastectomy, which also results in improved psychological health, self-esteem and body image,” Hershman wrote. “Owing to low rates of breast reconstruction, the Women’s Health and Cancer Rights Act was passed in 1998 and mandated that group health plans, health insurance companies and managed care organizations that cover the costs of mastectomy must also cover the costs of reconstruction. This public policy intervention was associated with an increased rate of breast reconstruction. Whether such coverage would extend to scalp-cooling devices is unclear.” – by Chuck Gormley
Nangia J, et al. JAMA. 2017;doi:10.1001/jama.2016.20939.
Rugo HS, et al. JAMA. 2017;doi:10.1001/jama.2016.21038.
Hershman DL. JAMA. 2017; doi:10.1001/jama.2016.21039.
For more information:
, MD, can be reached at Baylor College of Medicine, One Baylor Plaza, BCM 660, Houston, TX; email: email@example.com.
Paxman Coolers Ltd funded the study by Nangia and colleagues. Dignitana AB, the Lazlo Tauber Family Foundation, the Anne Moore Breast Cancer Research Fund and the Friedman Family Foundation funded the study by Rugo and colleagues. Nangia and Rugo report no relevant financial disclosures. Please see the full studies for lists of all other researchers’ relevant financial disclosures. Hershman reports no relevant financial disclosures.