Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04986579

Scalp Cooling in MBC

Led by Dana-Farber Cancer Institute · Updated on 2025-11-19

120

Participants Needed

2

Research Sites

347 weeks

Total Duration

On this page

Sponsors

D

Dana-Farber Cancer Institute

Lead Sponsor

P

Paxman Coolers Limited

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: * Paxman Scalp Cooling System

CONDITIONS

Official Title

Scalp Cooling in MBC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women with metastatic invasive breast cancer and an ECOG performance status of 2 or less
  • Age 18 years or older
  • Hair present at baseline
  • Planned full dose chemotherapy with sacituzumab govitecan, trastuzumab deruxtecan, or eribulin for at least 4 cycles
  • For those using scalp cooling, the Paxman Scalp Cooling System must start with the first chemotherapy dose
Not Eligible

You will not qualify if you...

  • Known blood cancers such as leukemia or lymphoma
  • Known scalp metastases
  • Baseline alopecia greater than grade 0
  • Cold agglutinin disease or cold urticaria
  • Scheduled for bone marrow ablation chemotherapy
  • History of migraines, cluster, or tension headaches unless resolved and approved by the investigator
  • Diagnosis of lichen planus or lupus
  • Receiving any other anti-cancer treatments

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

E

Elahe Salehi, DNP, ANP-BC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

6

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Scalp Cooling in MBC | DecenTrialz