{"id":"chemo-chair-comfort-devices-roadmap","name":"Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs","route":"/roadmaps/chemo-chair-comfort-devices-roadmap/","eras":[{"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.","status":"historic","refs":[{"id":"manual-cold-caps","kind":"technology","name":"Manual cold caps (Penguin and other frozen-gel caps)","route":"/technologies/manual-cold-caps/","status":"established","tldr":"Gel caps frozen in a cooler or dry ice and changed every 20 to 30 minutes by the patient or a helper, the older and portable alternative to scalp-cooling machines. None holds an FDA clearance for preventing hair loss."},{"id":"oral-cryotherapy-mucositis","kind":"technology","name":"Oral cryotherapy (ice chips) to prevent mucositis","route":"/technologies/oral-cryotherapy-mucositis/","status":"standard-of-care","tldr":"Sucking ice chips for half an hour around a bolus dose of fluorouracil or high-dose melphalan roughly halves the risk of painful mouth ulcers. It costs nothing and is recommended in international mucositis guidelines."}],"trials":[],"papers":[]},{"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.","status":"historic","refs":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/","status":"established","tldr":"A tightly fitted cap chilled to a few degrees above freezing, worn before, during and after each chemotherapy infusion, narrows the blood vessels of the scalp so less drug reaches the hair roots. In a randomised trial about half of women on taxane-based chemotherapy kept most of their hair, compared with none who went without."},{"id":"dignicap-cohort-trial","kind":"trial","name":"DigniCap pivotal cohort study","route":"/trials/dignicap-cohort-trial/","status":"positive","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."},{"id":"scalp-trial","kind":"trial","name":"SCALP randomised trial of the Paxman cooler","route":"/trials/scalp-trial/","status":"positive","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."},{"id":"dignitana","kind":"company","name":"Dignitana","route":"/companies/dignitana/","tldr":"Dignitana makes the DigniCap scalp cooling system, the first cooling cap the US FDA allowed on the market, in 2015, to reduce chemotherapy hair loss."},{"id":"paxman","kind":"company","name":"Paxman","route":"/companies/paxman/","tldr":"Paxman is the British maker of the Paxman Scalp Cooling System, a chilled cap worn during chemotherapy to reduce hair loss, cleared in the United States in 2017 and used in cancer centres across the world."}],"trials":[{"id":"dignicap-cohort-trial","name":"DigniCap pivotal cohort study","route":"/trials/dignicap-cohort-trial/","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"}],"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","enrolled":122,"enrolledNote":"122 patients (106 cooled, 16 controls) are reported in the JAMA paper; ClinicalTrials.gov NCT01831024 still shows an estimated 110.","enrolledBasis":"registered"},{"id":"scalp-trial","name":"SCALP randomised trial of the Paxman cooler","route":"/trials/scalp-trial/","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"}],"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","enrolled":182,"enrolledNote":"182 women were randomised by the interim analysis that stopped the trial; ClinicalTrials.gov NCT01986140 gives 236 enrolled.","enrolledBasis":"randomised"}],"papers":[]},{"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.","status":"current","refs":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/","status":"established","tldr":"A tightly fitted cap chilled to a few degrees above freezing, worn before, during and after each chemotherapy infusion, narrows the blood vessels of the scalp so less drug reaches the hair roots. In a randomised trial about half of women on taxane-based chemotherapy kept most of their hair, compared with none who went without."},{"id":"cooler-heads-care","kind":"company","name":"Cooler Heads Care","route":"/companies/cooler-heads-care/","tldr":"Cooler Heads makes Amma, a portable scalp-cooling system cleared by the FDA in 2021 that a patient can wear away from the infusion chair."},{"id":"stemtech-medical-devices","kind":"company","name":"Stemtech Medical Devices","route":"/companies/stemtech-medical-devices/","tldr":"Stemtech Medical Devices of Navi Mumbai makes the Eva scalp cooling system, the most recent machine cleared by the FDA to reduce chemotherapy hair loss."},{"id":"paxman","kind":"company","name":"Paxman","route":"/companies/paxman/","tldr":"Paxman is the British maker of the Paxman Scalp Cooling System, a chilled cap worn during chemotherapy to reduce hair loss, cleared in the United States in 2017 and used in cancer centres across the world."},{"id":"dignitana","kind":"company","name":"Dignitana","route":"/companies/dignitana/","tldr":"Dignitana makes the DigniCap scalp cooling system, the first cooling cap the US FDA allowed on the market, in 2015, to reduce chemotherapy hair loss."}],"trials":[],"papers":[]},{"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.","status":"current","refs":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/","status":"established","tldr":"A tightly fitted cap chilled to a few degrees above freezing, worn before, during and after each chemotherapy infusion, narrows the blood vessels of the scalp so less drug reaches the hair roots. In a randomised trial about half of women on taxane-based chemotherapy kept most of their hair, compared with none who went without."},{"id":"oncology-infusion-chairs","kind":"technology","name":"Oncology infusion and treatment chairs","route":"/technologies/oncology-infusion-chairs/","status":"standard-of-care","tldr":"Most chemotherapy is given to people sitting in a reclining chair for one to several hours, and with scalp cooling sometimes longer. The chair is a regulated but low-risk medical device, and almost nothing has been published about whether it is comfortable or safe for skin over long sessions."},{"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/","tldr":"Scalp cooling keeps patients in the chemotherapy chair for up to two hours longer, which limits how many people a unit can treat. Shorter cooling after the drip and portable coolers could free the chair without losing hair protection."}],"trials":[],"papers":[]},{"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.","status":"emerging","refs":[{"id":"limb-cryocompression-devices","kind":"technology","name":"Limb cryocompression devices for chemotherapy nerve damage (Paxman Neuropathy System, Hilotherm ChemoCare)","route":"/technologies/limb-cryocompression-devices/","status":"emerging","tldr":"Machine-cooled wraps that chill and gently squeeze the hands and feet during chemotherapy, in the hope of keeping drug away from the nerves that cause numbness and tingling. They are the machine version of frozen gloves, and the trials so far give mixed answers."},{"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/","status":"emerging","tldr":"Wearing frozen gloves and socks, or tight surgical gloves, during taxane infusions reduces nail damage and may reduce numbness in the hands and feet, by narrowing the blood vessels while the drug is at its peak. Trials are small but consistent, and it is cheap."},{"id":"control-cipn-trial","kind":"trial","name":"CONTRoL (cryotherapy against compression for neuropathy)","route":"/trials/control-cipn-trial/","status":"completed","tldr":"A small randomised trial comparing frozen gloves, tight gloves and loose gloves during taxane chemotherapy. Tight compression did best, partly because far more women kept it on than kept the cold gloves on."},{"id":"ice-compress-swog","kind":"trial","name":"ICE COMPRESS (SWOG, cooling or compression of limbs to prevent neuropathy)","route":"/trials/ice-compress-swog/","status":"recruiting","tldr":"A large US trial testing whether cooling, squeezing or both protect the nerves in the hands and feet during chemotherapy. It is the trial expected to settle a question small studies have left open."},{"id":"duke-cryocompression-gyn","kind":"trial","name":"Duke cryocompression trial in gynaecological cancer","route":"/trials/duke-cryocompression-gyn/","status":"positive","tldr":"Women having chemotherapy for gynaecological cancers wore a cooling-and-compression device. It reduced the numbness they reported, though a nerve test showed no difference."},{"id":"paxman","kind":"company","name":"Paxman","route":"/companies/paxman/","tldr":"Paxman is the British maker of the Paxman Scalp Cooling System, a chilled cap worn during chemotherapy to reduce hair loss, cleared in the United States in 2017 and used in cancer centres across the world."},{"id":"hilotherm","kind":"company","name":"Hilotherm","route":"/companies/hilotherm/","tldr":"Hilotherm is a German maker of water-circulating cooling devices, including ChemoCare wraps for hands and feet used in trials to prevent chemotherapy nerve damage."}],"trials":[],"papers":[]},{"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.","status":"speculative","refs":[{"id":"oncology-infusion-chairs","kind":"technology","name":"Oncology infusion and treatment chairs","route":"/technologies/oncology-infusion-chairs/","status":"standard-of-care","tldr":"Most chemotherapy is given to people sitting in a reclining chair for one to several hours, and with scalp cooling sometimes longer. The chair is a regulated but low-risk medical device, and almost nothing has been published about whether it is comfortable or safe for skin over long sessions."},{"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/","tldr":"People having chemotherapy can sit in the same chair for many hours, often thin and in pain, yet nobody seems to have studied whether infusion chairs cause pressure sores or discomfort. A simple study could find out."},{"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/","tldr":"Scalp cooling keeps patients in the chemotherapy chair for up to two hours longer, which limits how many people a unit can treat. Shorter cooling after the drip and portable coolers could free the chair without losing hair protection."},{"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/","tldr":"Frozen gloves, tight gloves and cooling machines all aim to protect the nerves during taxane chemotherapy, but many patients take the cold ones off. Matching the method to what each person tolerates may matter as much as which method is best on paper."},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/","tldr":"Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated."}],"trials":[],"papers":[]}],"watch":[]}