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Scalp Cooling for Hair Loss in Metastatic Breast Cancer

This study is testing how well the Paxman Scalp Cooling System works to prevent hair loss in people with metastatic breast cancer (cancer that has spread to other parts of the body). You can join if you are an adult with metastatic breast cancer, have hair, and are planning to receive certain chemotherapy treatments: Eribulin, Sacituzumab govitecan, or Trastuzumab deruxtecan. The main goal is to see the rate of hair loss in people who use scalp cooling compared to those who don't, over a period of up to two years. The study plans to enroll about 120 people. While the FDA has approved the Paxman system, this study specifically looks at its use with these particular chemotherapy drugs.

Study design
This is a controlled study, meaning some participants will use scalp cooling and others will not. About 120 people are expected to participate.
What's involved
You would undergo screening, have photographs taken, participate in hair loss assessments, complete questionnaires, and receive study treatment with scalp cooling during your chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2-4 weeks after completing chemotherapy treatment, with hair loss rates measured for up to 2 years.

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NCT04986579

Scalp Cooling in MBC

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Dana-Farber Cancer Institute
~120 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Paxman Scalp Cooling SystemEribulinSacituzumab govitecanTrastuzumab deruxtecan

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hair Loss Rate
Measured over Up to 2 years

Conditions

Metastatic Breast Cancer
Chemotherapy-induced Alopecia

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Elahe Salehi, DNP, ANP-BC · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Elahe Salehi, DNP, ANP-BC
[email protected]
617-632-3800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2
Participant is ≥ 18 years old.
Hair present at baseline.
One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:
Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle
Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks
Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle
The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.

Exclusion

Known hematological malignancies (i.e. leukemia or lymphoma)
Known scalp metastases.
Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B)
Subjects with cold agglutinin disease or cold urticaria.
Subjects who are scheduled for bone marrow ablation chemotherapy.
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, the subject may go on study at the discretion of the Principal Investigator.
Subjects who have lichen planus or lupus.
Participants who are receiving any additional anti-cancer agents

What this trial measures

  • Hair Loss RateUp to 2 years

    Hair loss rate defined as CTCAE v5.0 alopecia grade 1 or higher compared in the scalp cooling group using the Paxman Hair Loss Prevention System (PSCS) and group not using scalp cooling.