COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer

Smetanay, Katharina; Junio, Philippe; Feißt, Manuel; Seitz, Julia; Hassel, Jessica C.; Mayer, Luisa; Matthies, Lina Maria; Schumann, A.; Hennigs, André; Heil, Jörg; Sohn, Christof; Jaeger, Dirk; Schneeweiß, Andreas; Marmé, Frederik

doi:10.1007/s10549-018-4983-8

Cited by 44 publications

(53 citation statements)

References 30 publications

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“…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] ].…”

Section: Discussionsupporting

confidence: 93%

“…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] ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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Background Randomized controlled trials (RCT) of scalp cooling (SC) to prevent chemotherapy induced alopecia (CIA) did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted an RCT of SC in a setting of anthracycline (A) and taxane chemotherapy (CT) and assessed its effect on CIA and HR. Methods Non-metastatic breast cancer women undergoing (neo) adjuvant CT were randomized to receive SC using the Paxman scalp cooling system during every cycle of CT, or no SC. The primary end point (PEP) was successful hair preservation (HP) assessed clinically and by review of photographs after CT. HR was assessed at 6 and 12 weeks. Results 51 patients were randomized to SC (34) or control arm (17) in a 2:1 ratio. Twenty-five (49%) patients received A followed by T and the two arms were balanced with respect to this factor. HP rate was significantly higher in SC arm compared to control arm (56.3% vs 0%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; P < 0.001) and 12 weeks (100% vs 59%, P = 0.0003). Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016). There were no grade 3–4 cold related adverse effects. Conclusions Women with breast cancer receiving A or T chemotherapy receiving SC were significantly more likely to have less than 50% hair loss after CT, superior hair regrowth and improvement in patient reported outcomes, with acceptable tolerance. It merits wider usage.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

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

et al. 2020

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“…Chemotherapy-induced alopecia is generally reversible, and hair regrowth is predicted to begin 3–6 months after chemotherapy (21). Although most previous studies of scalp cooling have observed the degree of hair loss during the chemotherapy or 4 weeks after completion of chemotherapy (Table 5) (6, 7, 14–19), Smetanay et al reported that 6 months after chemotherapy, most patients experienced ≥75% hair recovery regardless of whether or not they used a scalp-cooling device (15). To the best of our knowledge, this is the first study to compare the hair recovery process in detail by independent assessors using a grading scale between patients who did and did not use scalp-cooling treatment.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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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.

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“…There might be risk factors of CIA, for example it might occur when a patient has an inflammatory lesion such as seborrheic eczema or a fragile vascular condition. Currently, only the scalp‐cooling device is effective to some extent as CIA prevention and has been clinically applied 20,21 . There are two known mechanisms of CIA prevention by the scalp‐cooling method: to inhibit the anticancer drug itself from reaching the peripheral blood vessels of the scalp by contracting the blood vessel, and to attenuate the action of the anticancer drug by deviating from the optimal temperature of the action of the anticancer drug.…”

Section: Discussionmentioning

confidence: 99%

Role of increased vascular permeability in chemotherapy‐induced alopecia: In vivo imaging of the hair follicular microenvironment in mice

et al. 2020

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Chemotherapy‐induced alopecia is one of the most difficult adverse events of cancer treatment for patients. However, it is still unknown why anticancer drugs cause hair loss. We aimed to clarify the mechanism of chemotherapy‐induced alopecia in mice using an in vivo imaging technique with a two‐photon microscope, which enables observation of the deep reaction in the living body in real time. In this study, ICR mice were injected intraperitoneally with cyclophosphamide (120 µg/g). Changes in the hair bulb morphology, subcutaneous vessel permeability, and vessel density were evaluated by two‐photon microscopy and conventional methods. In order to determine whether there is a causal relationship between vascular permeability and hair loss, we combined cyclophosphamide (50 µg/g) with subcutaneous histamine. We found that the hair bulbs became smaller, blood vessels around the hair follicle decreased in diameter, and vascular permeability was confirmed by two‐photon microscopy and conventional examination at 24 h after cyclophosphamide injection. Apoptosis occurred in vascular endothelial cells around the hair follicle. Additionally, hair loss was exacerbated by temporarily enhancing vascular permeability with histamine. In conclusion, cyclophosphamide caused a decrease in vascular density and an increase in vascular permeability, therefore increased vascular permeability might be one of the causes of chemotherapy‐induced alopecia.

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COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer

Cited by 44 publications

References 30 publications

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

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

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

Role of increased vascular permeability in chemotherapy‐induced alopecia: In vivo imaging of the hair follicular microenvironment in mice

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