Cooler caps may keep hair on during chemo
NCT ID NCT04180579
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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34 people
The number who actually took part.
- Started
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Nov 2019
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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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.
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