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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.
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.
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.
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.
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.
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.
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.
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.
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Shares Paxman, Limb cryocompression devices for chemotherapy nerve damage (Paxman Neuropathy System, Hilotherm ChemoCare) and the tag machines-wave3.
Shares Paxman, Limb cryocompression devices for chemotherapy nerve damage (Paxman Neuropathy System, Hilotherm ChemoCare) and the tag machines-wave3.
Shares Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants and the tag machines-wave3.
Shares SCALP randomised trial of the Paxman cooler, Fund scalp cooling and hair-preserving measures for every alopecia-inducing regimen, Scalp cooling (cold caps: DigniCap, Paxman), Toxicity and quality of life are undervalued.
Shares A prevention programme for chemotherapy nerve damage: SARM1 inhibitors, cooling and compression, Frozen gloves, socks and compression for taxane nail and nerve damage, Toxicity and quality of life are undervalued.
Shares A prevention programme for chemotherapy nerve damage: SARM1 inhibitors, cooling and compression, Frozen gloves, socks and compression for taxane nail and nerve damage, Survivorship and late effects are neglected, Toxicity and quality of life are undervalued.
Shares Frozen gloves, socks and compression for taxane nail and nerve damage, Scalp cooling (cold caps: DigniCap, Paxman), Toxicity and quality of life are undervalued.
Shares Fund scalp cooling and hair-preserving measures for every alopecia-inducing regimen, Scalp cooling (cold caps: DigniCap, Paxman).
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