RECRUITING

Scalp Cooling in MBC

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Conditions

Metastatic Breast CancerChemotherapy-induced Alopecia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Quick Facts

Study Start:2021-10-07
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04986579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2
  2. * Participant is ≥ 18 years old.
  3. * Hair present at baseline.
  4. * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:
  5. * Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle
  6. * Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks
  7. * Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle
  8. * 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.
  1. * Known hematological malignancies (i.e. leukemia or lymphoma)
  2. * Known scalp metastases.
  3. * Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B)
  4. * Subjects with cold agglutinin disease or cold urticaria.
  5. * Subjects who are scheduled for bone marrow ablation chemotherapy.
  6. * 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.
  7. * Subjects who have lichen planus or lupus.
  8. * Participants who are receiving any additional anti-cancer agents

Contacts and Locations

Study Contact

Elahe Salehi, DNP, ANP-BC
CONTACT
617-632-3800
elahe_salehi@dfci.harvard.edu

Principal Investigator

Elahe Salehi, DNP, ANP-BC
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Elahe Salehi, DNP, ANP-BC, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-07
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2021-10-07
Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

  • Metastatic Breast Cancer
  • Chemotherapy-induced Alopecia

Additional Relevant MeSH Terms

  • Metastatic Breast Cancer
  • Chemotherapy-induced Alopecia