This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Scalp Cooling in MBC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04986579
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : November 14, 2023
Sponsor:
Collaborators:
Paxman Coolers Limited
AstraZeneca
Eisai Inc.
Daiichi Sankyo
Gilead Sciences
Information provided by (Responsible Party):
Elahe Salehi, NP, Dana-Farber Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Chemotherapy-induced Alopecia Device: Paxman Scalp Cooling System Drug: Eribulin Drug: Sacituzumab govitecan Drug: Trastuzumab deruxtecan Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Scalp Cooling Cap

Drug: Eribulin
Intravenous Infusion
Other Name: 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 Name: 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 Name: Scalp Cooling Cap

Drug: Sacituzumab govitecan
Intravenous Infusion
Other Names:
  • Trodelvy
  • IMMU-132
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:
  • Trodelvy
  • IMMU-132
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 Name: 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04986579


Contacts
Layout table for location contacts
Contact: Elahe Salehi, DNP, ANP-BC 617-632-3800 elahe_salehi@dfci.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elahe Salehi, DNP, ANP-BC    617-632-3800    elahe_salehi@dfci.harvard.edu   
Principal Investigator: Elahe Salehi, DNP, ANP-BC         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elahe Salehi, DNP, ANP-BC    617-632-3800    elahe_salehi@dfci.harvard.edu   
Principal Investigator: Elahe Salehi, DNP, ANP-BC         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Paxman Coolers Limited
AstraZeneca
Eisai Inc.
Daiichi Sankyo
Gilead Sciences
Investigators
Layout table for investigator information
Principal Investigator: Elahe Salehi, DNP, ANP-BC Dana-Farber Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Elahe Salehi, NP, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04986579    
Other Study ID Numbers: 21-169
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: November 14, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Layout table for additional information
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
Keywords provided by Elahe Salehi, NP, Dana-Farber Cancer Institute:
Metastatic Breast Cancer
Chemotherapy-induced Alopecia
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Alopecia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
 Trastuzumab
Sacituzumab govitecan
Trastuzumab deruxtecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs