RecruitingPhase 2NCT04986579

Scalp Cooling in MBC

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer


Sponsor

Dana-Farber Cancer Institute

Enrollment

120 participants

Start Date

Oct 7, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether scalp cooling — wearing a special cold cap during chemotherapy — can prevent or reduce hair loss in people with metastatic breast cancer receiving specific chemotherapy regimens. Hair loss is one of the most distressing side effects of chemotherapy. **You may be eligible if...** - You are 18 or older with metastatic invasive breast cancer - You have hair at the start of the study - You are planned to receive one of these chemotherapy regimens for at least 4 cycles: sacituzumab govitecan, trastuzumab deruxtecan, or eribulin - Your general health status is acceptable (ECOG ≤2) **You may NOT be eligible if...** - You have a blood cancer (e.g., leukemia or lymphoma) - You have scalp metastases - You already have hair loss - You have migraine headaches - You have conditions worsened by cold (e.g., cold urticaria or cold agglutinin disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPaxman Scalp Cooling System

Cap attached to coolant lines connected to a refrigeration unit placed on scalp

DRUGEribulin

Intravenous Infusion

DRUGSacituzumab govitecan

Intravenous Infusion

DRUGTrastuzumab deruxtecan

Intravenous Infusion


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04986579


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