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

Abstract

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.

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

“…For this education to be effective, clinicians need to be aware of the available data on hair preservation and restoration associated with SC [8][9][10][11][12] and be able to counsel patients on the likelihood of success with various chemotherapy regimens. Decision aid websites are available (https://www.scalpcooling.org/ and https://coldcap.com/cold-capping/is-it-for-me/) that allow physicians to enter the type of chemotherapy and dose they plan to use for a particular patient and obtain an estimated success rate of hair retention with the use of SC that they can share with the patient.…”

“…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].…”

Scalp Cooling Impact in Alopecia of Patients Under Treatment for Breast Cancer—Literature Review

“…The cap decreases the scalp temperature promoting cutaneous vasoconstriction, which reduces local blood flow and absorption of the drug in the follicle. In addition, there is also an inhibition in the hair follicle cell metabolism, decreasing the chemotherapy cytotoxicity to scalp tissue [6,[15][16][17]. There are currently several types of scalp cooling devices available on the market.…”

Study validity depends on the study design and bias. Comment on “Randomised controlled trial of scalp cooling for the prevention of chemotherapy induced alopecia” by Bajpai et al. (The Breast. 2019 December 12. Doi: 10.1016/j.breast.2019.12.004 [Epub ahead of print])

“…This trial describes effects of scalp cooling on hair protection (HP) and regrowth (HR) in breast cancer patients [1].…”