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Cooler caps may keep hair on during chemo

NCT ID NCT04180579

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested if a scalp cooling cap set to a colder temperature than usual can safely prevent hair loss in breast cancer patients receiving chemotherapy. 34 adults with stage I-III breast cancer took part. The goal was to see if the lower temperature is safe and tolerable.

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

34 people

The number who actually took part.

Started

Nov 2019

Expected to finish

May 2027

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.

Ages

18 to 75 years

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: * Age 18 years or older * New diagnosis of breast cancer stage I-IV * Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent * Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen: * Concurrent trastuzumab at standard doses is allowed * Concurrent pertuzumab at standard doses is allowed * Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated * For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion. Exclusion Criteria: * Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) * Baseline alopecia (defined CTCAE v5.0 grade \> 1) * Subjects who are scheduled for bone marrow ablation chemotherapy * Male gender * Age \>/= 75 years * Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator. * Subjects who have had prior chemotherapy * Subjects who have had \>/=1 previous chemotherapy exposure resulting in alopecia * An existing history of scalp metastases or suspected presence of scalp metastasis * Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy * Previously received, or scheduled to undergo skull irradiation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

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