Scalp Cooling in MBC

Phase 2RecruitingNCT04986579

Dana-Farber Cancer Institute120 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

120

Conditions

Metastatic Breast Cancer Chemotherapy-induced Alopecia

Interventions

Paxman Scalp Cooling SystemDEVICE

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

EribulinDRUG

Intravenous Infusion

Sacituzumab govitecanDRUG

Intravenous Infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Hair Loss Rate

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.

Time frame: Up to 2 years

Secondary Outcomes

Change in Patient Reported Quality of Life

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).

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

Change in Patient Reported Quality of Life

Body image scale (BIS) will be used to assess patient reported positive quality of life changes using Paxman Hair Loss Prevention System (PSCS).

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.

Central Contacts

Elahe Salehi, DNP, ANP-BC

CONTACT

617-632-3800 elahe_salehi@dfci.harvard.edu

Data from ClinicalTrials.gov

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