Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer… (NCT04180579) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients
United States34 participantsStarted 2019-11-26
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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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 …
What they're measuring
1
Safety as assessed by CTCAE
Timeframe: Up to 44 weeks from the start of treatment