Scalp Cooling in MBC

November 13, 2023 updated by: Elahe Salehi, NP, Dana-Farber Cancer Institute

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®).

The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.

The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits.

Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy.

It is expected that about 120 people will take part in this research study.

Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Elahe Salehi, DNP, ANP-BC
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Elahe Salehi, DNP, ANP-BC

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Device: Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
Other Names:
  • Scalp Cooling Cap
Drug: Eribulin
Intravenous Infusion
Other Names:
  • Halaven
Active Comparator: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Drug: Eribulin
Intravenous Infusion
Other Names:
  • Halaven
Experimental: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Device: Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
Other Names:
  • Scalp Cooling Cap
Drug: Sacituzumab govitecan
Intravenous Infusion
Other Names:
  • IMMU-132
  • Trodelvy
Active Comparator: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Drug: Sacituzumab govitecan
Intravenous Infusion
Other Names:
  • IMMU-132
  • Trodelvy
Experimental: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)

Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Device: Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
Other Names:
  • Scalp Cooling Cap
Drug: Trastuzumab deruxtecan
Intravenous Infusion
Other Names:
  • Enhertu
  • DS-8201a
Active Comparator: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN.

Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.
Drug: Trastuzumab deruxtecan
Intravenous Infusion
Other Names:
  • Enhertu
  • DS-8201a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair Loss Rate
Time Frame: Up to 2 years
Hair loss rate defined as CTCAE v5.0 alopecia grade 1 or higher compared in the scalp cooling group using the Paxman Hair Loss Prevention System (PSCS) and group not using scalp cooling.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Reported Quality of Life
Time Frame: Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days
The Chemotherapy-Induced Alopecia Distress Scale (CADS) [25] will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days
Change in Patient Reported Quality of Life
Time Frame: Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days.
Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).
Baseline, Day 1 of cycle 3, day 1 of cycle 5, and after completing therapy or at the time of disease progression whichever occurs first up to 2 years. Cycle is 21 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Gilead Sciences
AstraZeneca
Daiichi Sankyo, Inc.
Eisai Inc.
Paxman Coolers Limited

Investigators

  • Principal Investigator: Elahe Salehi, DNP, ANP-BC, 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 Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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