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Purpose <p>Chemotherapy-induced alopecia (CIA) affects approximately 65% of patients receiving chemotherapy and has a negative impact on quality of life (QoL). Scalp cooling (SC) is the only FDA-cleared intervention for CIA. This systematic review and meta-analysis evaluated SC adverse events (AEs), reasons for discontinuation, and scalp metastasis incidence.</p> Methods <p>Meta-analyses using random-effects models estimated pooled prevalences of SC AEs, SC discontinuation, and reasons for discontinuation. A generalized linear mixed model was used to estimate the incidence of scalp metastasis.</p> Results <p>Sixty-seven studies met the inclusion criteria. The most common AEs were generalized chills (42%, 95% confidence interval (CI) 26–58%), cap heaviness (35%, 95% CI 18–52%), and headache (30%, 95% CI 21–39%). The SC discontinuation rate was 18% (95% CI 13–23%). The most common reasons for discontinuation were progressive alopecia (15%, 95% CI 10–20%) and reasons unrelated to SC (9%, 95% CI 5–13%). The most frequent AEs leading to SC discontinuation were headache (4%, 95% CI 2–6%), cold intolerance (4%, 95% CI 3–5%), and general discomfort (4%, 95% CI 2–7%). Secondary analysis of scalp metastases yielded an incidence of 0.15% (95% CI 0.05–0.47%). Analysis of FDA Manufacturer and User Facility Device Experience (MAUDE) database medical device reports revealed that user error contributed to cold thermal injuries. Prevalence estimates were limited by significant heterogeneity between studies, reflecting variations in study methodology and real-world SC practices.</p> Conclusion <p>SC is generally well tolerated with minimal safety concerns. Clinical comfort strategies like supportive medications and improved patient education could enhance SC tolerability and support its implementation.</p>

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Adverse effects of scalp cooling for the reduction of chemotherapy-induced alopecia: A systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2025年11月21日

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  • Caitlin A. Kearney,
  • Anna L. Brinks,
  • Carli D. Needle,
  • Samrachana Adhikari,
  • Douglas K. Marks,
  • Jerry Shapiro,
  • Ian W. Tattersall,
  • Kristen I. Lo Sicco,
  • Mario E. Lacouture

摘要

Purpose

Chemotherapy-induced alopecia (CIA) affects approximately 65% of patients receiving chemotherapy and has a negative impact on quality of life (QoL). Scalp cooling (SC) is the only FDA-cleared intervention for CIA. This systematic review and meta-analysis evaluated SC adverse events (AEs), reasons for discontinuation, and scalp metastasis incidence.

Methods

Meta-analyses using random-effects models estimated pooled prevalences of SC AEs, SC discontinuation, and reasons for discontinuation. A generalized linear mixed model was used to estimate the incidence of scalp metastasis.

Results

Sixty-seven studies met the inclusion criteria. The most common AEs were generalized chills (42%, 95% confidence interval (CI) 26–58%), cap heaviness (35%, 95% CI 18–52%), and headache (30%, 95% CI 21–39%). The SC discontinuation rate was 18% (95% CI 13–23%). The most common reasons for discontinuation were progressive alopecia (15%, 95% CI 10–20%) and reasons unrelated to SC (9%, 95% CI 5–13%). The most frequent AEs leading to SC discontinuation were headache (4%, 95% CI 2–6%), cold intolerance (4%, 95% CI 3–5%), and general discomfort (4%, 95% CI 2–7%). Secondary analysis of scalp metastases yielded an incidence of 0.15% (95% CI 0.05–0.47%). Analysis of FDA Manufacturer and User Facility Device Experience (MAUDE) database medical device reports revealed that user error contributed to cold thermal injuries. Prevalence estimates were limited by significant heterogeneity between studies, reflecting variations in study methodology and real-world SC practices.

Conclusion

SC is generally well tolerated with minimal safety concerns. Clinical comfort strategies like supportive medications and improved patient education could enhance SC tolerability and support its implementation.