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Cold caps may keep hair during chemo

NCT ID NCT03289364

Symptom relief Sponsor: Providence Health & Services Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether wearing special cold caps (Penguin caps) during chemotherapy could prevent or reduce hair loss in people with early-stage breast cancer. Twelve participants used the caps while getting one of four common chemo regimens. The goal was to see if at least half of them kept most of their hair (less than 50% loss) one month after treatment ended.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Aug 2017

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least ≥ 18 years of age * Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned. * Willing and able to provide informed consent. * Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique. * Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy. Exclusion Criteria: * Pre-existing alopecia (Dean's scale ≥ 1) * Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment. * Prior radiotherapy treatment involving head. * Pre-existing chronic severe headaches or migraines. * Skin conditions that in the opinion of PI would be at risk of worsening with study. * Cold sensitivity or cold agglutinin disease * Cryoglobulinemia * Cryofibrogenemia * History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.

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Conditions

The condition(s) this trial relates to.

alopecia breast cancer breast neoplasm chemotherapy-induced alopecia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Providence Cancer Center

    Portland, Oregon, 97213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.