Efficacy of Scalp Cooling in Preventing and Recovering From Chemotherapy-Induced Alopecia in Breast Cancer Patients: The HOPE Study

Abstract

Purpose: This study aimed to assess the efficacy of scalp-cooling devices in preventing chemotherapy-induced alopecia in Japanese breast cancer patients and investigate whether a scalp-cooling device improves hair volume recovery over a 12 weeks period after completing chemotherapy. Methods: This multicenter controlled trial included women with breast cancer undergoing chemotherapy in Japan between February 2016 and March 2018. The primary endpoint was the proportion of patients with no alopecia at the end of chemotherapy. The secondary endpoint included hair volume at 12 weeks after completing chemotherapy. Results: A total of 48 patients were enrolled; of them, 34 and 14 were sequentially allocated to the scalp-cooling group using the Paxman Hair Loss Prevention System and the control group, respectively. There was no significant difference in average age between the scalp-cooling and the control groups (50.0 ± 9.6 vs. 49.0 ± 9.0 years). More than 50% of patients in each group had stage II breast cancer (scalp-cooling group: 53.1%; control group: 64.3%), more than 90% received adjuvant chemotherapy (scalp-cooling group: 96.9%; control group: 92.9%), and more than 60% were treated with a docetaxel/cyclophosphamide regimen (scalp-cooling group: 75.0%; control group: 64.3%). There were more patients judged to have no alopecia at the end of chemotherapy in the scalp-cooling group than in the control group (26.7% [8/30] vs. 0% [0/13]; P = 0.011). The proportion of patients with alopecia who experienced an increase in hair volume of ≥50% within 12 weeks duration after chemotherapy was 85.7% (24/28) in the scalp-cooling group and 50.0% (6/12) in the control group. No patient developed serious adverse events related to the scalp-cooling device. Conclusions: The use of a scalp-cooling device prevented alopecia with acceptable safety for Japanese patients. In addition, scalp cooling resulted in faster recovery of hair volume after chemotherapy, even in patients for whom scalp cooling failed to prevent chemotherapy-induced alopecia.

“Randomised controlled trial of scalp cooling for the prevention of chemotherapy induced alopecia”

“…Our study suggests that women with breast cancer who received SC with both A and T chemotherapy were significantly more likely (57% versus 0%) to have successful HP than those who did not receive SC. This is consistent with results from recent studies which show success of scalp cooling in ∼30–80% patients [ [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] ]. Also, though SC has mostly been studied in females undergoing treatment for breast cancer, many of the studies are in patients with early breast cancer [ 13 , 14 , 16 , [26] , [27] , [28] , [29] ].…”

“…This could be attributed to multiple cancer types being enrolled in trials, varied CT regimens, intrinsic patient/hair characteristics, technical reasons like optimal cap fit, and use of non-validated outcome measures (use of wigs, subjective hair loss assessment) [ 3 , 6 , 11 ]. A meta-analysis as well as other randomized control trials (RCTs) showed positive results with SC with acceptable tolerance [ 9 , [12] , [13] , [14] ]. Various other non-randomized studies have also reported beneficial outcomes with SC [ [15] , [16] , [17] , [18] , [19] ].…”

Unraveling the Heterogeneity of Sarcoma Survivors’ Health-Related Quality of Life Regarding Primary Sarcoma Location: Results from the SURVSARC Study

“…Hair thinning was the most common problem reported by the breast cancer survivors (75.0%), followed by reduced hair volume (53.9%), hair loss (34.6%), and grey hair (34.6%) [ 30 ]. Hair problems can affect a person’s self-image, therefore clinicians should be aware of this distressing long-term issue and should properly inform patients about this side effect or about prevention strategies such as scalp cooling [ 30 , 31 ]. Additionally for the other locations, treatment-specific issues were found which require attention, for example, difficulties seeing themselves naked for breast sarcomas, urine incontinence for uterus sarcomas, or speaking problems for head and neck sarcomas, issues that will probably have an impact on the survivors’ HRQoL.…”

Integration of Physician and Nursing Professional Efforts to Deliver Supportive Scalp Cooling Care to Oncology Patients at Risk for Alopecia

“…Efficacy of SC is based on a visual inspection of the patient's scalp by a clinician during physical exam, or on a patient's alopecia selfreport. SC significantly reduces the risk of CIA from taxane-based and anthracycline-based chemotherapy regimens [8][9][10][11][12]. The majority of studies have been conducted in patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy with curative intent [13,14].…”