The results of Paxman’s first randomised US scalp cooling trial are to be published in Journal of American Medical Association (JAMA). Find the abstract here.
Background
Having made its submission for FDA clearance, Paxman will be delighted to see the airing of positive results from what is the first randomized study to assess modern scalp cooling to prevent alopecia. Especially as results from similar non-randomized trials have varied historically.
The Scalp Cooling Alopecia Prevention trial (SCALP) carried out at Paxman’s lead US trial site, studied the effectiveness of scalp cooling therapy in reducing hair loss in women undergoing taxane or anthracycline chemotherapy regimens.
The research was conducted by 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.
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, randomized on a 2 to 1 ratio to determine if they received the scalp cooling device versus no cooling therapy.
The primary study objective was to determine the safety and efficacy of the scalp cooling device in reducing hair loss in patients undergoing chemotherapy. Secondary endpoints included whether patients in the cooling arm required use of a wig or scarf and overall quality of life, as scored by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30, the Hospital Anxiety and Depression Scale and a summary scale of the Body Image Scale.
Patients in the trial 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.
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 of grade 0 or 1, meaning no wig or scarf was needed, compared to 0 (0 percent) out of 47 in the no cooling group. The results crossed the superiority boundary and resulted in researchers ceasing to accrue patients and halting the study early to release the data.
The conclusion then is that scalp cooling using the Paxman Hair Loss Prevention System is highly effective in hair preservation after the fourth chemotherapy cycle for patients who receive taxane or anthracycline, or both, chemotherapy for stage I or II breast cancer.
Mild side effects such as headaches and temporary discomfort were reported. No serious adverse device events were reported. Patients involved in the scalp cooling study will be followed for five years to determine any adverse effects, including scalp metastases, along with recurrence and overall survival. There were no significant differences in quality of life scores between the control and scalp cooling groups after four chemotherapy cycles.
The interim analysis has already been presented at the 2016 San Antonio Breast Cancer Symposium in December. Further research is needed to assess longer-term efficacy and adverse effects.
Investigator comments
Dr Nangia stated: “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.”
“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.”
“Variation in hair retention seen across the sites is likely a result of different types of chemotherapy administered, as 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.”
“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.”
Company comments
Richard Paxman, CEO at Paxman, said: “It is such an honour that our clinical trial findings, used in the FDA submission have been published in JAMA. It is a real privilege for not only the researchers involved but for all the patients that took part in the trials. Hair loss is one of the most traumatic and outwardly visible side effects for many women undergoing chemotherapy treatment for breast cancer and we are doing everything we can to quite literally change the face of cancer.”
Source: Paxman Coolers Ltd
published: February 15, 2017 in: Clinical Studies/Trials, Oncology, Regulatory