{"entity":{"id":"dignicap-cohort-trial","kind":"trial","name":"DigniCap pivotal cohort study","aka":["Efficacy and Safety of Dignicap System for Preventing Chemotherapy Induced Alopecia"],"tldr":"Women with early breast cancer having chemotherapy without an anthracycline used the DigniCap cooling cap. Two thirds lost half their hair or less, against none of a small comparison group.","summary":"The DigniCap study included 106 women who used the cap and 16 controls at five US centres between August 2013 and October 2014; it was a prospective cohort, not randomised. The scalp was held at 3 degrees Celsius from 30 minutes before chemotherapy to 90 to 120 minutes after. Hair loss of 50 per cent or less on the Dean scale was seen in 67 of 101 evaluable cooled women (66.3 per cent) and 0 of 16 controls; three of five quality-of-life measures were better a month after chemotherapy. The study supported the De Novo authorisation of the DigniCap in December 2015 (DEN150010), which created the FDA's scalp-cooling device type.","status":"positive","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT01831024","url":"https://clinicaltrials.gov/study/NCT01831024"},{"label":"Rugo et al., DigniCap prospective cohort with concurrent controls (JAMA 2017)","url":"https://doi.org/10.1001/jama.2016.21038"},{"label":"FDA De Novo DEN150010: DigniCap System (8 December 2015)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN150010"}],"tags":["machines-wave3"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":["dignitana"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"nct":"NCT01831024","phase":"not-applicable","setting":"Women with stage I or II breast cancer on adjuvant or neoadjuvant chemotherapy without an anthracycline, at five US centres, with a small concurrent control group","sponsor":"Target Health Inc. (for Dignitana)","result":"Hair loss of 50 per cent or less in 66.3 per cent of cooled women against 0 per cent of controls.","started":"2013-07","yearReported":2017,"enrolled":122,"enrolledBasis":"registered","enrolledNote":"122 patients (106 cooled, 16 controls) are reported in the JAMA paper; ClinicalTrials.gov NCT01831024 still shows an estimated 110.","outcomes":[{"endpoint":"Dean score 0 to 2 (50 per cent hair loss or less) 4 weeks after chemotherapy","primary":true,"unit":"%","arms":[{"name":"DigniCap","n":101,"value":66.3},{"name":"Concurrent controls","n":16,"value":0}],"source":"https://doi.org/10.1001/jama.2016.21038"}]},"route":"/trials/dignicap-cohort-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":"dignitana","kind":"company","name":"Dignitana","route":"/companies/dignitana/"}],"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/"}]}}