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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
122 registered.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Dean score 0 to 2 (50 per cent hair loss or less) 4 weeks after chemotherapyprimary | DigniCap | 101 | 66.3% | - | - | link |
| Concurrent controls | 16 | 0% |
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman), Breast cancer (all types) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman), Breast cancer (all types) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Breast cancer (all types) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs, Scalp cooling (cold caps: DigniCap, Paxman), Breast cancer (all types) and the tag machines-wave3.
Shares Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs and the tag machines-wave3.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/