Background: Alopecia is a common and distressing adverse effect of curative-intent chemotherapy in early stage breast cancer. Machine-based scalp cooling (such as Paxman® or DigniCap®) is effective for alopecia reduction/prevention, however availability of these devices is geographically limited. Cold-cap based systems are FDA-approved alternatives that can be accessed by motivated patients regardless of geographic location. Cold-cap based systems were shown to be highly effective in prospective trials, however dedicated research staff were responsible for cold-cap implementation in these trials. Here, we report the results of a pilot study to evaluate efficacy of cold-capping under real world conditions whereby patients and caretakers are responsible for cold-cap implementation.

Methods: Key eligibility criteria included: 1) no hair loss at baseline (Dean’s scale 0); 2) no pre-existing scalp condition; 3) planned curative-intent chemo (ACT/HP, TC, TCHP, or TH); and 4) availability of caretaker(s) to assist with cold-cap implementation. Patients and caretakers were required to undergo a standardized cold-capping training session, which included didactic and hands-on simulation designed to educate on proper cold-capping use as advised by the manufacturer (Penguin®). The primary endpoint was 30-day post-treatment hair retention using the Dean’s alopecia score, with success defined as <50% hair loss (score 0-2 on 5-point scale). Secondary outcomes included toxicity (CTCAEv4.0) and patient-reported outcomes (“Was it Worth It” scale).

Results: Twelve patients were enrolled and underwent training. Two patients withdrew consent before initiating treatment. 80% (n=8/10) of evaluable patients met the primary efficacy endpoint of Dean’s scale 0-2 (table 1). Trial failures were reported in 2 patients (20%), one due to treatment discontinuation and another due to >50% hair loss. One cap-related toxicity of grade 1 head sore was reported. 90% (n=10) of subjects reported that participation was worthwhile (“yes” on Was it Worth It? scale).

Conclusions: With the assistance of a hospital-sponsored training session, caretaker-implemented cold-capping is effective at preventing/reducing alopecia, and is worthwhile to patients. Efficacy was observed even with anthracycline-based chemotherapy. Cold-cap scalp cooling may serve as an alternative to machine-based scalp cooling, and is available to interested patients regardless of geographic location. Scholarships are available to subsidize the cost of cold-capping for patients in need.

Clinical Trial Outcomes

ArmRegimen"Was it Worth it?" QuestionnaireFinal Dean's Alopecia Scale Score
Arm 1 (n=3) ACT/HP Yes: 3/3 (100%) 1: 2/3 (66%); 2: 1/3 (33%) 
Arm 2 (n=5) TCH/P Yes: 4/5 (80%; Unknown: 1/5 (20%) 0: 2/5 (40%); 1: 2/5 (40%); 3: 1/5 (20%) 
Arm 3 (n=1) TC Yes: 1/1 (100%) 2: 1/1 but discontinued early (100%) 
Arm 4 (n=1) T/H Yes: 1/1 (100%) 0: 1/1 (100%) 
Total (n=10)  Yes: 9/10 (90%); Unknown: 1/10 (10%) 0: 3/10 (30%); 1: 4/10 (40%); 2: 2/10 (20%); 3: 1/10 (10%) 
ArmRegimen"Was it Worth it?" QuestionnaireFinal Dean's Alopecia Scale Score
Arm 1 (n=3) ACT/HP Yes: 3/3 (100%) 1: 2/3 (66%); 2: 1/3 (33%) 
Arm 2 (n=5) TCH/P Yes: 4/5 (80%; Unknown: 1/5 (20%) 0: 2/5 (40%); 1: 2/5 (40%); 3: 1/5 (20%) 
Arm 3 (n=1) TC Yes: 1/1 (100%) 2: 1/1 but discontinued early (100%) 
Arm 4 (n=1) T/H Yes: 1/1 (100%) 0: 1/1 (100%) 
Total (n=10)  Yes: 9/10 (90%); Unknown: 1/10 (10%) 0: 3/10 (30%); 1: 4/10 (40%); 2: 2/10 (20%); 3: 1/10 (10%) 

Citation Format: Manaz Rezayee, Alison K Conlin, Janet Ruzich, Nicole Fredrich, Amanda Y Seino, Susan Mulligan, Tracy L Kelly, Julie Cramer, Walter J Urba, David B Page. A pilot evaluation of cold-capping efficacy under real world conditions for the prevention of chemotherapy-induced alopecia in early stage breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-12-14.