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

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    33
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 1 July 2022
cyclophosphamide
anthracyclines
pertuzumab
trastuzumab
taxane
breast cancer stage i
adjuvant chemotherapy
immunostimulant
breast cancer staging

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.

Details
Condition Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Treatment PAXMAN Scalp Cooler
Clinical Study IdentifierNCT04180579
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on1 July 2022

Eligibility

Yes No Not Sure

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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