Breast Cancer Clinical Trial
Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients
This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.
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.
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
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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