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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer Stage I; Breast Cancer; Breast Cancer Stage III; Breast Cancer Stage II
• Interventions: Device: PAXMAN Scalp Cooler

• Registration Number: NCT04180579
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 34

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Breast Cancer	PAXMAN Scalp Cooler	Any adult woman with a new diagnosis of breast cancer, Stage I-III

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States