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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04180579

Collaborator

(none)

Enrollment

Location

Arm

41.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III	Device: PAXMAN Scalp Cooler	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 26, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Breast Cancer Any adult woman with a new diagnosis of breast cancer, Stage I-III	Device: PAXMAN Scalp Cooler Scalp cooling will occur with each dose of chemotherapy.

Arm

Intervention/Treatment

Experimental: Participants with Breast Cancer

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

Device: PAXMAN Scalp Cooler

Scalp cooling will occur with each dose of chemotherapy.

Outcome Measures

Primary Outcome Measures

Safety as assessed by CTCAE [Up to 44 weeks from the start of treatment]
Safety will be determined by toxicity assessment according to CTCAE

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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