Scalp Cooling in MBC

  • STATUS
    Recruiting
  • End date
    Jun 1, 2026
  • participants needed
    120
  • sponsor
    Dana-Farber Cancer Institute
Updated on 23 March 2022

Summary

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

Description

This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®).

The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.

The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits.

Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy.

It is expected that about 120 people will take part in this research study.

Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.

Details
Condition Metastatic Breast Cancer, Chemotherapy-induced Alopecia
Treatment Eribulin, Sacituzumab govitecan, Trastuzumab deruxtecan, Paxman Scalp Cooling System
Clinical Study IdentifierNCT04986579
SponsorDana-Farber Cancer Institute
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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