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

NCT04180579 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

PAXMAN Scalp Cooler

Scalp cooling will occur with each dose of chemotherapy.

Sponsors & Collaborators

Principal Investigators

  • Shari Goldfarb, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180579 on ClinicalTrials.gov