Introduction

Chemotherapy-induced alopecia (CIA) is a common and emotionally distressing side effect for patients with early-stage breast cancer. Scalp cooling (SC) systems, such as Paxman® and DigniCap®, have been approved by the FDA for the prevention of CIA, but their availability is geographically limited. This study explores the efficacy of manual scalp cooling (using systems such as Penguin Cold Cap), in combination with standardised caregiver training, to assess its impact on hair preservation and patient experience.

Target

The aim of the study was to evaluate the efficacy of manual scalp cooling in the prevention of ASD in patients with early breast cancer, as well as the value of caregiver training in improving outcomes and patient satisfaction.

Methods

A pilot study was conducted with 10 evaluable patients, who received curative chemotherapy and used the Penguin Cold Cap system. Designated caregivers to assist with scalp cooling received standardised training. Effectiveness was measured using the Dean alopecia scale 30 days after treatment, with a focus on hair retention (<50% hair loss, score 0-2). Exit interviews were also conducted to assess patient experience.

Results

• Scalp Cooling Effectiveness: 80% of patients (8 out of 10) achieved the primary goal of retaining more than 50% of hair, with Dean alopecia scores of 0-2. Only 1 patient reported the use of head coverings to disguise hair loss. There were two trial failures due to premature discontinuation of treatment.
• Scalp Cooling Safety: Of the 16 adverse events reported, only one (6,25%) was possibly related to scalp cooling, consisting of mild head discomfort.

Analysis

• Scalp Cooling Effectiveness: Manual scalp cooling was effective in most patients in preventing ASD, with a success rate of 80%. Caregiver training was critical to maximise this efficacy, as correct application of the system was crucial for positive outcomes.
• Scalp Cooling Safety: The system was well tolerated, with very few related adverse effects. This suggests that manual scalp cooling is a safe option for most patients.
• Heterogeneity of the studies: While the study showed promising results, the small sample of patients and the lack of a control group limit the generalisability of the results. Larger, controlled studies are needed to confirm these findings.
• Quality of Life and Psychological Outcomes: Patient-reported assessments showed improvements in emotional function and future outlook after treatment. Most participants felt that scalp cooling improved their quality of life by allowing them to maintain a more «normal» appearance, which reduced the emotional impact of the treatment.

Key Facts

• Alopecia Risk Reduction: 80% of patients retained more than 50% of their hair.
• Relative Risk (RR): No RR was specified in this study.
• Number of Participants: 10 evaluable patients.
• Type of chemotherapy: Regimens including ACT/HP, TCH/P, TC, and TH.
• Adverse Events: Only one mild adverse event related to scalp cooling was reported (mild headache).

Conclusion

The study concludes that manual scalp cooling is an effective and safe option for the prevention of chemotherapy-induced alopecia in patients with early breast cancer. Standardised training of caregivers is crucial to maximise treatment efficacy. Although the results are promising, more research is needed to validate these findings and to develop clinical tools to help patients make informed decisions about the use of scalp cooling.

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