Scalp Cooling: What Hair Preservation Meant in Two Studies

If a clinic quotes a scalp-cooling success rate, ask how much hair loss still counted as success, who assessed it and when. Also ask whether the participants received your chemotherapy regimen.

SCALP: the randomized trial

SCALP randomized 182 women with stage I or II breast cancer to Paxman cooling or no cooling; its published interim analysis included 142. After four chemotherapy cycles, success meant no loss or less than 50% loss without requiring a wig, assessed by a clinician unaware of treatment assignment.¹

48 of 95 cooling participants, 50.5%, met that endpoint, versus none of 47 controls. Only five cooling participants, 5.3%, had no hair loss.¹

The trial stopped early for benefit. Results varied by center and chemotherapy type; the four-cycle endpoint could miss later loss. Quality-of-life scale changes did not differ significantly between groups. Paxman funded the study.¹

DigniCap: the observational study

A separate 2017 prospective cohort study² used DigniCap in women receiving non-anthracycline chemotherapy for early-stage breast cancer. It enrolled 106 cooling participants and 16 controls; the primary analysis included 101 cooling participants. This was not randomized.²

At four weeks after chemotherapy ended, success meant patient-assessed loss of 50% or less. It occurred in 67 of 101 cooling participants, 66.3%, and none of the 16 controls. Only five cooling participants were classified as having no hair loss. Dignitana partly funded the study.²

The 66.3% and 50.5% figures should not be used to rank the devices. The studies differed in chemotherapy, assessment, timing and design. Neither was a direct comparison between those two systems.¹²

Match the evidence to your treatment plan

The American Cancer Society’s³ guidance, revised in April 2026, says response depends on the chemotherapy type or dose; anthracycline-containing regimens may be less responsive. Cap fit also matters, with poor contact linked to patchy loss.³

The FDA’s⁴ 2017 expanded DigniCap clearance concerned reducing the frequency and severity of chemotherapy-related hair loss in patients with solid tumors. Its announcement also states that the device may not work with some regimens. Clearance does not provide a personal prediction of hair retention.⁴

Bring the names, doses and planned sequence of your cancer drugs to the discussion. Ask the team which published results most closely match that schedule and whether those results cover the entire treatment course. Ask what they count as success: a hair-loss category, avoiding a wig, your own assessment, or something else.

Decide what would make the effort worthwhile

Scalp cooling starts with the first chemotherapy treatment and continues before, during and after each session. The American Cancer Society³ lists headache, nausea, dry skin, claustrophobia and cold discomfort among possible side effects. It is unsuitable for some patients, including those with blood cancers and certain cold-related conditions. Eligibility belongs with the oncology team.³

Ask for the session length, fitting plan, total expected cost and instructions for reporting discomfort. Discuss how you would decide to continue or stop if shedding occurs, and what support is available either way. You can ask about scarves, wigs or other coverings while also considering cooling.

Hair, Everywhere includes “Your Hair Log,” with dated photos and a record of products or medicines and their start dates. Those recordkeeping prompts can help organize observations; your oncology team should set the assessment schedule during chemotherapy.