Using scalp cooling to prevent hair loss in metastatic breast cancer patients
Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
This study is testing if using a scalp cooling system during chemotherapy can help prevent hair loss in people with metastatic breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | Sacituzumab, Trastuzumab, chemotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04986579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older with a diagnosis of metastatic invasive breast cancer who have hair present at baseline and are scheduled to receive specific chemotherapy regimens.
Not a fit: Patients with known hematological malignancies, scalp metastases, or baseline alopecia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hair loss for patients undergoing chemotherapy for metastatic breast cancer.
How similar studies have performed: Previous studies have shown success with scalp cooling in preventing hair loss during chemotherapy, but this specific application with the mentioned drugs is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.