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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04180579
• Other study ID #: 19-277
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms

Intervention

Device:
• PAXMAN Scalp Cooler
Scalp cooling will occur with each dose of chemotherapy.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by CTCAE	Safety will be determined by toxicity assessment according to CTCAE	Up to 44 weeks from the start of treatment

External Links

•   Memorial Sloan Kettering Cancer Center