Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients

Conditions
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Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Intervention / Treatment
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* Device: PAXMAN Scalp Cooler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Breast Cancer<br>Any adult woman with a new diagnosis of breast cancer, Stage I-III | Device: PAXMAN Scalp Cooler<br>* Scalp cooling will occur with each dose of chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as assessed by CTCAE | Safety will be determined by toxicity assessment according to CTCAE | Up to 44 weeks from the start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia, breast cancer, hair loss, chemotherapy induced alopecia, 19-277, Memorial Sloan Kettering Cancer Center