# SCALP: scalp cooling to prevent hair loss during chemotherapy for early breast cancer

Source: https://onco.cc/key-papers/paper-scalp-trial-jama-2017/  
OnCo record `paper-scalp-trial-jama-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In the first randomised trial of a modern scalp cooling system, half the women who used the Paxman device during taxane or anthracycline chemotherapy for early breast cancer kept most of their hair, compared with none of those who did not.

## Summary

SCALP was a multicentre randomised trial at seven US centres of the Paxman Orbis scalp cooling system in women with stage I or II breast cancer receiving at least four cycles of taxane-based, anthracycline-based or combined chemotherapy, randomised 2:1 to cooling or no cooling. The primary endpoint was hair preservation, defined as Dean scale grade 0 or 1 (less than 50 percent hair loss without the need for a wig) after four cycles.

At the planned interim analysis of 142 evaluable women, 48 of 95 (50.5 percent) in the cooling group preserved their hair compared with 0 of 47 in the control group, and the trial stopped early for efficacy. Preservation was better with taxane-only regimens than with anthracycline-containing regimens. Adverse events were mild (headache, chills, scalp pain) and there were no scalp metastases during follow-up. Quality-of-life measures did not differ significantly at four cycles. A companion single-arm study of the DigniCap system (Rugo et al., same issue) reported hair preservation in 66.3 percent of women on non-anthracycline taxane regimens versus none of 16 concurrent controls. Together the two studies underpinned FDA clearance of both devices for solid tumours.

## Fields

- Kind: Key paper
- Last checked: 2026-09-10
- Tags: complementary; hair-loss
- Journal: JAMA
- Year: 2017
- DOI: 10.1001/jama.2016.20939
- Authors: Nangia J, Wang T, Osborne C, et al.
- Findings: 182 women randomised; interim analysis of 142 evaluable: hair preservation 50.5% (48/95) with scalp cooling versus 0% (0/47) without.; Preservation higher with taxane-only than anthracycline-containing chemotherapy.; Adverse events limited to grade 1-2 headache, chills and scalp discomfort; no scalp metastases.; Companion DigniCap study: 66.3% hair preservation on non-anthracycline taxane regimens versus 0% in controls.
- What it means: Scalp cooling works, especially for taxane-based regimens, and is safe. The question moved from whether to how to make it available: device time in the chemotherapy chair, staff training, and who pays.
- Caveats: Open-label; the outcome was assessed by clinicians and patients who knew the allocation.; Stopped early at interim analysis, which can overestimate effect size.; Anthracycline-containing regimens, common in breast cancer, had lower preservation rates.

## Sources

- SCALP randomised trial (JAMA 2017): https://doi.org/10.1001/jama.2016.20939
- DigniCap prospective cohort with concurrent controls (JAMA 2017): https://doi.org/10.1001/jama.2016.21038
- Scalp cooling and the risk of scalp metastases: systematic review (Breast Cancer Res Treat 2017): https://doi.org/10.1007/s10549-017-4185-9

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Scalp cooling (cold caps: DigniCap, Paxman)](https://onco.cc/technologies/scalp-cooling/)
- drugs: [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Docetaxel](https://onco.cc/drugs/docetaxel/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- bottlenecks: [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- journals: [JAMA](https://onco.cc/journals/jama/)

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