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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Cancer Stage II; Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage III

Treatments: Device: PAXMAN Scalp Cooler

Study type: Interventional

Funder types: Other

Identifiers

NCT04180579

19-277

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Participants with Breast Cancer

Experimental group

Description:

Any adult woman with a new diagnosis of breast cancer, Stage I-III

Treatment:

Device: PAXMAN Scalp Cooler