Abstract P6-11-19: Efficacy and patient acceptability of the DigniCaP ScalpCooler to prevent hair loss in breast cancer patients receiving adjuvant chemotherapy

Abstract

Background: Alopecia is a common and distressing adverse effect in breast cancer (BC) patients (pts) receiving adjuvant chemotherapy. The aim of the study was to assess the effectiveness and safety of this device to prevent chemotherapy-induced alopecia in early breast cancer patients (EBCP) receiving adjuvant treatment. The quality of life of pts was also evaluated. Patients and methods: From January to December 2016, a sensor-controlled scalp cooling system (DigniCap:Sysmex Europe GmbH, Norderstedt, Germany) was proposed to a consecutive group of EBCP submitted to adjuvant chemotherapy at the Breast Unit of Spedali Civili Hospital of Brescia. Degree of hair loss was assessed by two nurse using Dean's alopecia scale by digital photographs at baseline and each chemotherapy cycle. EORTC QLQ-C30 questionnaire and self-reported visual analogical scale (VAS) of symptoms (anxiety, tone of mood, fatigue, nausea,well-being, activity) were collected at baseline and after the first two cycles of chemotherapy. Results: 70 pts were enrolled and 49 (70%) completed the chemotherapy plan and were evaluable. Median age was 51 years, 8 pts (16%) received neoadjuvant and 41 pts (84%) adjuvant chemotherapy, 21 (43%) were treated with 4 cycle of chemotherapy (TC, EC or paclitaxel alone), and 28 (57%) with sequential chemotherapy with antracycline and taxane +- trastuzumab. Fifteen pts (30%) stopped the treatment because of loss of hair in 9 pts, for headache in 4 pts and for other problems in 2 pts. At the end of chemotherapy, 13 pts (27%) had no loss of hair (Dean score 0), 25 pts (51%) had a minimal loss of hair (Dean score 1), 9 pts (18%) had a 50% hair loss (Dean score 2), 2 pts (4%) had a 75% hair loss (Dean score 3). No pts reported hair loss more than 75% (Dean score 4). There wasn't a significant difference between mean score value of QLQ-C30 at baseline and after chemotherapy and between the groups with and without hair loss. VAS documented an increase of fatigue and decrease of anxiety from baseline to final evaluation. The side effects presented with the use of DigniCap were the following: headache in 32% of pts and cold feeling in 57 % of pts. Conclusion: Scalp cooling with cold caps appears to be effective in preventing CIA among the majority of women undergoing treatment chemotherapy. The quality of life did not change in scalp-cooled patients. Acknowledgments: a thank you to the ESA association that donated Dignicap to Oncology Department. Citation Format: Vassalli L, Pedersini R, Romelli M, Claps M, Fornaro C, Conti E, Tagliani M, Baronchelli A, Ragni D, Lombardi E, Rodella F, Amoroso V, Berruti A, Simoncini EL. Efficacy and patient acceptability of the DigniCaP ScalpCooler to prevent hair loss in breast cancer patients receiving adjuvant chemotherapy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-11-19.

Mental health-related impact applying a scalp cooling technology solution in chemotherapy: a scoping review

“…Regarding the positive psychological impact of the DigniCap technology, preventing CIA and improving the quality of life was not signi cantly detected. Vassalli et al (2018) reported no signi cant changes in the quality of life pre-and post-treatment, and even reported an increase in fatigue; by contrast, only anxiety seemed to have decreased in this cohort. Similarly, Pochilo et al ( 2019) reported a decrease in anxiety level with an increase in depressive thoughts.…”

“…Clinical trials (Cigler et al, 2017;Smetanay et al, 2018;Munzone et al, 2019) have been conducted mostly from a multicentric perspective and observational studies. In cohort study designs (Rugo et al, 2012;Fehr et al, 2016;Rugo et al, 2017;Vassalli et al, 2018;Chan et al, 2019;Giarratano et al, 2019;Prochilo et al, 2019;Orlando et al, 2019) prospective observational studies have been conducted mostly in multicentric research, focusing on CIA and quality of life, satisfaction, and patient-reported performance variables in an oncological population diagnosed with breast cancer. All studies reported a good rate of success for the DigniCap technology associated with chemotherapy treatment, particularly, regarding hair loss (average: 25% of CIA).…”