{"entity":{"id":"scalp-trial","kind":"trial","name":"SCALP randomised trial of the Paxman cooler","aka":["SCALP trial"],"tldr":"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).","status":"positive","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT01986140","url":"https://clinicaltrials.gov/study/NCT01986140"},{"label":"Nangia et al., the SCALP randomised trial (JAMA 2017)","url":"https://doi.org/10.1001/jama.2016.20939"},{"label":"FDA 510(k) K163484: Paxman Scalp Cooler (17 April 2017)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K163484"}],"tags":["machines-wave3"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":["paxman"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-scalp-trial-jama-2017"],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"nct":"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)","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.","started":"2014-05-15","startedType":"actual","yearReported":2017,"enrolled":182,"enrolledBasis":"randomised","enrolledNote":"182 women were randomised by the interim analysis that stopped the trial; ClinicalTrials.gov NCT01986140 gives 236 enrolled.","outcomes":[{"endpoint":"Hair preservation (CTCAE grade 0 to 1) after four cycles","primary":true,"unit":"%","arms":[{"name":"Scalp cooling","n":95,"value":50.5},{"name":"No cooling","n":47,"value":0}],"source":"https://doi.org/10.1001/jama.2016.20939"}]},"route":"/trials/scalp-trial/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"technology":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/"}],"company":[{"id":"paxman","kind":"company","name":"Paxman","route":"/companies/paxman/"}],"paper":[{"id":"paper-scalp-trial-jama-2017","kind":"paper","name":"SCALP: scalp cooling to prevent hair loss during chemotherapy for early breast cancer","route":"/key-papers/paper-scalp-trial-jama-2017/"}],"roadmap":[{"id":"chemo-chair-comfort-devices-roadmap","kind":"roadmap","name":"Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs","route":"/roadmaps/chemo-chair-comfort-devices-roadmap/"}]}}