# Manual cold caps (Penguin and other frozen-gel caps)

Source: https://onco.cc/technologies/manual-cold-caps/  
OnCo record `manual-cold-caps` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

Before machine scalp coolers were cleared, hair preservation meant a series of frozen gel caps, swapped as each warmed. They are still used, rented by the month and carried in by patients, because they need no machine in the unit. Every FDA authorisation under the scalp-cooling classification (21 CFR 878.4360, product code PMC) belongs to a refrigerated machine; no manual cap appears there. Penguin's own page says only that the materials are approved in Canada and by the FDA, and a gel cap listed by Polygel LLC as "Chemo Cold Cap" is registered as a reusable hot or cold pack (Class I, exempt), not cleared for alopecia.

Published results are single-institution series. In a retrospective study of 100 patients using Penguin caps, 92.1 per cent of 89 evaluable kept at least half their hair, with 71.4 per cent success on doxorubicin-containing regimens against 95.7 per cent with paclitaxel and 96.6 per cent with docetaxel. Without a randomised comparison against machines, the trade-off is practical: caps are portable and need no unit equipment, but the temperature varies as each cap warms and a helper must change them on time.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-11-04
- Also known as: Cold caps; Penguin Cold Caps; Chemo Cold Caps; Arctic Cold Caps; Frozen gel caps
- Tags: machines-wave3
- Principle: Frozen gel caps cool the scalp to narrow its blood vessels during the infusion peak, as machine coolers do, but the temperature rises between changes.
- Strengths: Need no machine in the unit; can be used anywhere; Single-centre series report high success with taxanes; Rental lets patients choose without unit purchase
- Limitations: No FDA clearance for alopecia; Temperature varies between cap changes; needs a trained helper; No randomised comparison with machine cooling

## Sources

- Weaver et al., Penguin cold caps in 100 patients at one institution (Support Care Cancer 2024): https://doi.org/10.1007/s00520-024-08393-7
- Penguin Cold Caps: https://penguincoldcaps.com/
- 21 CFR 878.4360, scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4360
- openFDA 510(k) records under product code PMC (scalp cooling system): https://api.fda.gov/device/510k.json?search=product_code:PMC&limit=20

## Connected records

- ideas: [Finish scalp cooling away from the infusion chair](https://onco.cc/ideas/idea-mach-cooling-off-the-chair/), [Fund scalp cooling and hair-preserving measures for every alopecia-inducing regimen](https://onco.cc/ideas/idea-moon-hair-preservation-for-all/)
- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Recovery & Rejuvenation](https://onco.cc/fronts/rejuvenation/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- technologies: [Oncology infusion and treatment chairs](https://onco.cc/technologies/oncology-infusion-chairs/), [Scalp cooling (cold caps: DigniCap, Paxman)](https://onco.cc/technologies/scalp-cooling/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- bottlenecks: [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- roadmaps: [Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs](https://onco.cc/roadmaps/chemo-chair-comfort-devices-roadmap/)

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