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Cool cap could save hair during breast cancer chemo

NCT ID NCT05508984

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

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a special cooling cap, called the Amma system, can help women with early-stage breast cancer keep more of their hair during chemotherapy. Fifteen women will use the cap during each chemo session and answer questions about how satisfied they are. The goal is to see if the cap is practical and helpful enough to offer in more cancer clinics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amma Cooling Caps (a scalp cooling device)
What this could lead to
If successful, this could offer a practical way for breast cancer patients to keep more of their hair during chemotherapy, improving their comfort and self-image.
What could go wrong
This is a very small pilot study with only 15 people, so results may not apply to everyone. The device might not work well for all hair types or chemotherapy regimens.

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.

Participants

15 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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.

Who is studied

Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.

Ages

18 years and older

Sex

Female participants only

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: \- Women with stage I-III breast cancer are eligible to participate if: * They consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews * They consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes * Curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: TC x 4, T x 12, TCHP x6)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

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 Institute - Newberg Clinic

    Newberg, Oregon, 97132, United States

  • Providence Oncology and Hematology Care - Westside

    Portland, Oregon, 97225, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

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