Scalp Cooling in MBC

Metastatic Breast Cancer Clinical Trial

Official title:

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986579
• Other study ID #: 21-169
• Status: Recruiting
• Phase: Phase 2
• Start date: October 7, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Dana-Farber Cancer Institute
• Contact: Elahe Salehi, DNP, ANP-BC
• Phone: 617-632-3800
• Email: elahe_salehi[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Breast Neoplasms
• Chemotherapy-induced Alopecia
• Metastatic Breast Cancer

Intervention

Device:
• Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp

Drug:
• Eribulin
Intravenous Infusion
• Sacituzumab govitecan
Intravenous Infusion
• Trastuzumab deruxtecan
Intravenous Infusion

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	AstraZeneca, Daiichi Sankyo, Eisai Inc., Gilead Sciences, Paxman Coolers Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 years
Secondary	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).	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
Secondary	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).	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.