Determination of the most effective cooling temperature for the prevention of chemotherapy-induced alopecia

Abstract

Computer-controlled scalp cooling to prevent alopecia is currently available for patients undergoing chemo-therapy. Previous studies have suggested that the temperature should be <22°C at a depth of 1-2 mm in the scalp to prevent alopecia. However, the optimal pre-set temperature of the coolant medium to achieve this temperature requires further investigation. A pre-study was conducted to investigate which pre-set coolant temperature of 3 and 8°C was the most effective in achieving a scalp temperature of <22°C. The temperature variations at different sites of the scalp and variations within and among the participants at baseline and during the cooling procedure were also evaluated. A randomized main study was then performed to compare the efficacy and side effects of the two temperature levels during paclitaxel/carboplatin chemotherapy. A group of 5 healthy female volunteers participated in a series of scalp temperature measurements during cooling with 3 and 8°C of the coolant medium. In the randomized main study, a total of 47 patients were included, of whom 43 were evaluable after the first cycle. A pre-set temperature of 3°C tended to be the most efficient in achieving a hair follicle temperature of <22°C. The top of the head was less responsive to scalp cooling. There were no significant differences in the prevention of alopecia between the two temperatures in the main study. However, headache and a feeling of coldness were more common in the 3°C group. A coolant temperature of 3°C was more effective in achieving a subcutaneous temperature of <22°C. However, this finding was not reflected by a significant difference in the prevention of alopecia in this study, although a higher incidence of side effects was associated with a lower temperature level.

Efficacy of the DigniCap System in preventing chemotherapy‐induced alopecia in breast cancer patients is not related to patient characteristics or side effects of the device

“…Alopecia during chemotherapy is a distressing adverse event that negatively affects patients' quality of life. Recently published meta‐analyses of randomized controlled trials comparing scalp cooling versus no scalp cooling showed a reduction in the relative risk of alopecia ranging from 43% to 62% (Ekwall, Nygren, Gustafsson, & Sorbe, 2013; Rugo & Voigt, 2018). As summarized in Table 6, our results are shared by clinical trials that reported a hair preservation rate of nearly 60% in EBC patients receiving chemotherapy with anthracyclines and/or taxanes (Fehr et al, 2016; Friedrichs & Carstensen, 2014).…”

Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines

“…Scalp temperature was to be maintained at 3–5 °C throughout chemotherapy and for 90 min to 120 min afterward, depending on the chemotherapy drug and dose, resulting in a scalp temperature of ~15 °C. 8 …”

“…Scalp temperature was to be maintained at 3-5°C throughout chemotherapy and for 90 min to 120 min afterward, depending on the chemotherapy drug and dose, resulting in a scalp temperature of~15°C. 8 Assessment of hair loss Hair loss (HL) was evaluated by patient self-assessment and by the medical personnel according to the Dean's scale [grade 0 (no HL), 1 (<25% HL), 2 (25-50% HL), 3 (50-75% HL) and 4 (>75% HL)] by means of five standardised photographs taken prior to each chemotherapy cycle and at the end of planned treatment.…”

Hypothermia for preventing chemotherapy-induced neuropathy – a pilot study on safety and tolerability in healthy controls

“…Our study has demonstrated for the first time that 22 C is the lowest temperature uniformly well tolerated for three hours in healthy subjects. It is important to note that scalp cooling trials have investigated and demonstrated that temperatures lower than 22 C are critical for preventing CIA, with clinical trials employing as low as 3 C [18], however, with reported intolerability. In contrast, our study has established the lowest well tolerated temperature, which is a crucial factor to tap the benefit of limb hypothermia by sustained administration.…”