{"entity":{"id":"chemo-chair-comfort-devices-roadmap","kind":"roadmap","name":"Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs","aka":[],"tldr":"The devices that make the hours in the chemotherapy chair more bearable and protect hair, nails and nerves: frozen caps, then refrigerated scalp-cooling machines cleared from 2015, portable coolers, cooling and compression for hands and feet, and the chair itself.","summary":"Seven devices have FDA authorisation under the scalp-cooling product code PMC (21 CFR 878.4360), whose special controls require labelling on the potential risk of scalp metastasis: DigniCap by De Novo in December 2015 (DEN150010), the Paxman Scalp Cooler in April 2017 (K163484) on the SCALP trial, both extended to solid tumours in 2017 and 2018, DigniCap Delta in 2019, Cooler Heads' portable Amma in 2021 and Stemtech's Eva in November 2025. Dignitana became part of the Paxman Group in June 2025. Manual frozen caps predate them and hold no clearance. Shorter post-infusion cooling (20 minutes as effective as 45 or 90 with weekly paclitaxel; under 85 minutes sufficient in a 4,680-patient registry) and portable coolers both shorten chair time. Limb cryocompression applies the same idea to neuropathy, with mixed randomised results and a SWOG phase 3 trial running. The chair itself is a low-risk regulated device on which OnCo found no oncology study of comfort or pressure injury.","asOf":"2026-11-04","links":[{"label":"21 CFR 878.4360, scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia (eCFR)","url":"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4360"},{"label":"FDA De Novo DEN150010: DigniCap System (8 December 2015)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN150010"},{"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"},{"label":"FDA 510(k) K170871: DigniCap, solid tumours (3 July 2017)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170871"},{"label":"FDA 510(k) K173032: Paxman, solid tumours (7 June 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173032"},{"label":"FDA 510(k) K191166: DigniCap Delta (26 June 2019)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191166"},{"label":"FDA 510(k) K211526: Cooler Heads portable system (21 October 2021)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211526"},{"label":"FDA 510(k) K252289: Eva Scalp Cooling System (25 November 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289"},{"label":"Dignitana, part of the Paxman Group from 1 June 2025","url":"https://dignitana.com/"},{"label":"Lugtenberg et al., 20 versus 45 minutes of post-infusion scalp cooling with weekly paclitaxel, randomised trial (Support Care Cancer 2022)","url":"https://doi.org/10.1007/s00520-022-07090-7"},{"label":"Breed et al., post-infusion cooling time in 4,680 patients, Dutch Scalp Cooling Registry (Support Care Cancer 2025)","url":"https://doi.org/10.1007/s00520-025-09526-2"},{"label":"Kaufman et al., duration of scalp cooling and how it fits the infusion day: a review (Support Care Cancer 2025)","url":"https://doi.org/10.1007/s00520-025-10058-y"},{"label":"Weaver et al., Penguin cold caps in 100 patients at one institution (Support Care Cancer 2024)","url":"https://doi.org/10.1007/s00520-024-08393-7"},{"label":"Paxman: the Paxman Neuropathy System (limb cryocompression)","url":"https://paxmangroup.com/reduce-nerve-damage/paxman-neuropathy/"},{"label":"Champion Healthcare Solutions: oncology and infusion medical recliners","url":"https://championchair.com/clinical-applications/oncology-infusion-chairs/"},{"label":"Slayton et al., pressure mapping of a standard hospital recliner in 34 healthy adults (J Wound Ostomy Continence Nurs 2017)","url":"https://doi.org/10.1097/won.0000000000000300"}],"tags":["machines-wave3"],"related":["devices-roadmap","idea-moon-hair-preservation-for-all","idea-moon-neuropathy-prevention-programme","idea-mach-cooling-off-the-chair","idea-mach-infusion-chair-pressure-study","idea-mach-cold-or-compression-by-adherence"],"cancers":[],"sections":["supportive-care","chemotherapy","devices"],"technologies":["scalp-cooling","manual-cold-caps","limb-cryocompression-devices","frozen-gloves-compression-taxane","oral-cryotherapy-mucositis","oncology-infusion-chairs","infusion-devices-vascular-access"],"targets":[],"drugs":[],"companies":["paxman","dignitana","cooler-heads-care","stemtech-medical-devices","hilotherm"],"institutions":[],"pathways":[],"terms":[],"trials":["scalp-trial","dignicap-cohort-trial","ice-compress-swog","control-cipn-trial"],"people":[],"bottlenecks":["b-toxicity-qol","b-survivorship"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"steps":[{"era":"Before 2015","title":"Frozen caps and ice","description":"Gel caps frozen and changed every 20 to 30 minutes, and ice chips in the mouth during bolus fluorouracil, came before the machines. Ice chips remain a standard for mucositis; caps remain in use without clearance, with single-centre series reporting high success on taxanes and lower success with doxorubicin.","refs":["manual-cold-caps","oral-cryotherapy-mucositis"],"status":"historic"},{"era":"2015-2018","title":"Refrigerated scalp coolers cleared","description":"DigniCap received De Novo authorisation in December 2015 (DEN150010), creating the device type, on a cohort study in which 66.3 per cent of women on non-anthracycline regimens lost half their hair or less. The Paxman Scalp Cooler was cleared in April 2017 (K163484) on the SCALP trial (hair preserved in 50.5 against 0 per cent). Both were extended to solid tumours in 2017 and 2018.","refs":["scalp-cooling","dignicap-cohort-trial","scalp-trial","dignitana","paxman"],"status":"historic"},{"era":"2019-2025","title":"New models, portable coolers and consolidation","description":"DigniCap Delta (K191166, 2019); Cooler Heads' Amma (K211526, 2021), indicated for home use; Stemtech's Eva (K252289, November 2025), cleared without clinical data as substantially equivalent to DigniCap Delta. Dignitana joined the Paxman Group in June 2025.","refs":["scalp-cooling","cooler-heads-care","stemtech-medical-devices","paxman","dignitana"],"status":"current"},{"era":"2022-2025","title":"Less time in the chair","description":"A randomised trial with weekly paclitaxel found 20 minutes of post-infusion cooling as effective as 45 and 90 minutes, and the Dutch registry of 4,680 patients found no added benefit beyond about 85 minutes. A 2025 review names chair time as a barrier and notes that cooling stations outside the infusion chair have been proposed.","refs":["scalp-cooling","oncology-infusion-chairs","idea-mach-cooling-off-the-chair"],"status":"current"},{"era":"2016-2031","title":"Cooling and compression for hands and feet","description":"Frozen gloves and compression reduced taxane neuropathy in small self-controlled studies; machine cryocompression gives a steady temperature. Randomised results are mixed (CROPSI found it no better than cryotherapy; CONTRoL favoured compression, with twice the adherence), and SWOG's 777-patient ICE COMPRESS trial is expected to report after 2030.","refs":["limb-cryocompression-devices","frozen-gloves-compression-taxane","control-cipn-trial","ice-compress-swog","duke-cryocompression-gyn","paxman","hilotherm"],"status":"emerging"},{"era":"Next","title":"The chair as a measured device","description":"Treatment chairs are low-risk regulated devices sold for oncology infusion, yet no study of their comfort or of pressure injury in oncology patients was found; the only pressure-mapping study used healthy adults. Measuring chair outcomes, moving cooling off the chair, and choosing cold or compression by what patients can keep on are the proposals here.","refs":["oncology-infusion-chairs","idea-mach-infusion-chair-pressure-study","idea-mach-cooling-off-the-chair","idea-mach-cold-or-compression-by-adherence","b-toxicity-qol"],"status":"speculative"}],"watch":[]},"route":"/roadmaps/chemo-chair-comfort-devices-roadmap/","neighbours":{"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}],"idea":[{"id":"idea-moon-neuropathy-prevention-programme","kind":"idea","name":"A prevention programme for chemotherapy nerve damage: SARM1 inhibitors, cooling and compression","route":"/ideas/idea-moon-neuropathy-prevention-programme/"},{"id":"idea-mach-cold-or-compression-by-adherence","kind":"idea","name":"Choose cold or compression for neuropathy by what patients can keep on","route":"/ideas/idea-mach-cold-or-compression-by-adherence/"},{"id":"idea-mach-cooling-off-the-chair","kind":"idea","name":"Finish scalp cooling away from the infusion chair","route":"/ideas/idea-mach-cooling-off-the-chair/"},{"id":"idea-moon-hair-preservation-for-all","kind":"idea","name":"Fund scalp cooling and hair-preserving measures for every alopecia-inducing regimen","route":"/ideas/idea-moon-hair-preservation-for-all/"},{"id":"idea-mach-infusion-chair-pressure-study","kind":"idea","name":"Measure skin pressure and comfort in oncology infusion chairs","route":"/ideas/idea-mach-infusion-chair-pressure-study/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"frozen-gloves-compression-taxane","kind":"technology","name":"Frozen gloves, socks and compression for taxane nail and nerve damage","route":"/technologies/frozen-gloves-compression-taxane/"},{"id":"infusion-devices-vascular-access","kind":"technology","name":"Infusion pumps, ports, and ambulatory chemotherapy devices","route":"/technologies/infusion-devices-vascular-access/"},{"id":"limb-cryocompression-devices","kind":"technology","name":"Limb cryocompression devices for chemotherapy nerve damage (Paxman Neuropathy System, Hilotherm ChemoCare)","route":"/technologies/limb-cryocompression-devices/"},{"id":"manual-cold-caps","kind":"technology","name":"Manual cold caps (Penguin and other frozen-gel caps)","route":"/technologies/manual-cold-caps/"},{"id":"oncology-infusion-chairs","kind":"technology","name":"Oncology infusion and treatment chairs","route":"/technologies/oncology-infusion-chairs/"},{"id":"oral-cryotherapy-mucositis","kind":"technology","name":"Oral cryotherapy (ice chips) to prevent mucositis","route":"/technologies/oral-cryotherapy-mucositis/"},{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/"}],"company":[{"id":"cooler-heads-care","kind":"company","name":"Cooler Heads Care","route":"/companies/cooler-heads-care/"},{"id":"dignitana","kind":"company","name":"Dignitana","route":"/companies/dignitana/"},{"id":"hilotherm","kind":"company","name":"Hilotherm","route":"/companies/hilotherm/"},{"id":"paxman","kind":"company","name":"Paxman","route":"/companies/paxman/"},{"id":"stemtech-medical-devices","kind":"company","name":"Stemtech Medical Devices","route":"/companies/stemtech-medical-devices/"}],"trial":[{"id":"control-cipn-trial","kind":"trial","name":"CONTRoL (cryotherapy against compression for neuropathy)","route":"/trials/control-cipn-trial/"},{"id":"dignicap-cohort-trial","kind":"trial","name":"DigniCap pivotal cohort study","route":"/trials/dignicap-cohort-trial/"},{"id":"duke-cryocompression-gyn","kind":"trial","name":"Duke cryocompression trial in gynaecological cancer","route":"/trials/duke-cryocompression-gyn/"},{"id":"ice-compress-swog","kind":"trial","name":"ICE COMPRESS (SWOG, cooling or compression of limbs to prevent neuropathy)","route":"/trials/ice-compress-swog/"},{"id":"scalp-trial","kind":"trial","name":"SCALP randomised trial of the Paxman cooler","route":"/trials/scalp-trial/"}],"bottleneck":[{"id":"b-survivorship","kind":"bottleneck","name":"Survivorship and late effects are neglected","route":"/bottlenecks/b-survivorship/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}]}}