Study on Scalp Cooling for Hair Loss Prevention in Metastatic Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04986579

Provider View

This study is exploring whether using a scalp cooling system can help reduce hair loss in people with metastatic breast cancer who are receiving specific chemotherapy treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare hair loss in people with metastatic breast cancer who use a scalp cooling system versus those who do not. The study focuses on patients receiving chemotherapy treatments with sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The Paxman Scalp Cooling System is being tested to see if it can help prevent hair loss during these treatments. Participants will be monitored for hair loss and other effects during and after their chemotherapy sessions.

Description

This study is designed to see if the Paxman Scalp Cooling System can help prevent hair loss in people undergoing treatment for metastatic breast cancer with specific chemotherapy drugs: Sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The Paxman Scalp Cooling System is already approved by the FDA for preventing hair loss during chemotherapy, but it hasn't been specifically tested with these drugs.

Participants will go through several steps, including eligibility screening, taking photographs, assessing hair loss, filling out questionnaires, and receiving the scalp cooling treatment along with their chemotherapy. They will be followed for 2-4 weeks after finishing their chemotherapy to monitor results.

About 120 people are expected to participate in this study. The Paxman Scalp Cooling System is provided by Paxman Coolers Limited, a company that makes medical devices.

Eligibility Criteria

Inclusion Criteria

  • Men and women diagnosed with metastatic invasive breast cancer, with a performance status score of 2 or less.
  • Must be 18 years or older.
  • Must have hair at the start of the study.
  • Must be planning to receive at least 4 cycles of one of the following chemotherapy treatments:
    • Sacituzumab govitecan (10 mg/kg) given intravenously on days 1 and 8 of each 21-day cycle.
    • Trastuzumab deruxtecan (5.4 mg/kg) given intravenously once every 3 weeks.
    • Eribulin (1.4 mg/m2) given intravenously on days 1 and 8 of each 21-day cycle.
  • The scalp cooling must start with the first dose of chemotherapy for those choosing to use it.

Exclusion Criteria

  • Have blood cancers like leukemia or lymphoma.
  • Have cancer that has spread to the scalp.
  • Have existing hair loss (alopecia) before starting the study.
  • Have conditions like cold agglutinin disease or cold urticaria.
  • Scheduled for bone marrow ablation chemotherapy.
  • Have a history of migraines or severe headaches unless resolved.
  • Have skin conditions like lichen planus or lupus.
  • Receiving any additional anti-cancer treatments.

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