Using scalp cooling to prevent hair loss in metastatic breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to compare hair loss rates in patients with metastatic breast cancer who use the Paxman Scalp Cooling System during chemotherapy against those who do not. Participants will receive standard chemotherapy treatments, including sacituzumab govitecan, trastuzumab deruxtecan, or eribulin, while utilizing the scalp cooling system. The study will involve screening for eligibility, hair loss assessments, and follow-up evaluations over a period of 2-4 weeks after chemotherapy completion. Approximately 120 individuals are expected to participate in this pivotal study.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Elahe Salehi, DNP, ANP-BC — Dana-Farber Cancer Institute
• Study coordinator: Elahe Salehi, DNP, ANP-BC
• Email: elahe_salehi@dfci.harvard.edu
• Phone: 617-632-3800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.