Clinical trial NCT04180579: Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients
Official title: Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Keywords: alopecia
breast cancer
hair loss
chemotherapy induced alopecia
19-277
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety as assessed by CTCAE
timeFrame: Up to 44 weeks from the start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Shari Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References: