# SCALP randomised trial of the Paxman cooler

Source: https://onco.cc/trials/scalp-trial/  
OnCo record `scalp-trial` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Women having chemotherapy for early breast cancer were randomly assigned to wear a machine-cooled cap or not. About half of those who used the cap kept most of their hair; none of the others did.

## Summary

SCALP randomised 182 women at seven US sites to Paxman scalp cooling (119) or no cooling (63). At the planned interim analysis 142 were evaluable: 36 per cent had anthracycline-based and 64 per cent taxane-based chemotherapy. Hair preservation (grade 0 or 1 alopecia) was seen in 48 of 95 women who used cooling (50.5 per cent) and 0 of 47 controls; because the result crossed the superiority boundary, the data and safety monitoring board recommended stopping the trial on 26 September 2016. There were no significant differences in quality-of-life scales by cycle four. The result supported the FDA clearance of the Paxman Scalp Cooler in April 2017 (K163484).

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-11-04
- Also known as: SCALP trial
- Tags: machines-wave3
- Registry id: NCT01986140
- Phase: not-applicable
- Setting: Women with stage I or II breast cancer starting four or more cycles of taxane or anthracycline chemotherapy, randomised 2 to 1 to the Paxman Orbis scalp cooler or no cooling
- Sponsor: Julie Nangia (Baylor College of Medicine)
- Enrolled: 182
- Result: Hair preserved in 50.5 per cent of women with scalp cooling against 0 per cent without, at interim analysis; stopped early for efficacy.
- Outcomes: Hair preservation (CTCAE grade 0 to 1) after four cycles: Scalp cooling 50.5% vs No cooling 0%

## Sources

- ClinicalTrials.gov NCT01986140: https://clinicaltrials.gov/study/NCT01986140
- Nangia et al., the SCALP randomised trial (JAMA 2017): https://doi.org/10.1001/jama.2016.20939
- FDA 510(k) K163484: Paxman Scalp Cooler (17 April 2017): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163484

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- technologies: [Scalp cooling (cold caps: DigniCap, Paxman)](https://onco.cc/technologies/scalp-cooling/)
- companies: [Paxman](https://onco.cc/companies/paxman/)
- key papers: [SCALP: scalp cooling to prevent hair loss during chemotherapy for early breast cancer](https://onco.cc/key-papers/paper-scalp-trial-jama-2017/)
- roadmaps: [Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs](https://onco.cc/roadmaps/chemo-chair-comfort-devices-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/scalp-trial.json