NCT04180579

Brief Summary

This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

6.4 years

First QC Date

November 26, 2019

Last Update Submit

June 2, 2025

Conditions

Breast CancerBreast Cancer Stage IBreast Cancer Stage IIBreast Cancer Stage III

Keywords

alopeciabreast cancerhair losschemotherapy induced alopecia19-277Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Safety as assessed by CTCAE

    Safety will be determined by toxicity assessment according to CTCAE

    Up to 44 weeks from the start of treatment

Study Arms (1)

Participants with Breast Cancer

EXPERIMENTAL

Any adult woman with a new diagnosis of breast cancer, Stage I-III

Device: PAXMAN Scalp Cooler

Interventions

PAXMAN Scalp CoolerDEVICE

Scalp cooling will occur with each dose of chemotherapy.

Participants with Breast Cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • New diagnosis of breast cancer stage I-IV
  • Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
  • Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen:
  • Concurrent trastuzumab at standard doses is allowed
  • Concurrent pertuzumab at standard doses is allowed
  • Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
  • For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion.

You may not qualify if:

  • Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
  • Baseline alopecia (defined CTCAE v5.0 grade \> 1)
  • Subjects who are scheduled for bone marrow ablation chemotherapy
  • Male gender
  • Age \>/= 75 years
  • 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, subject may go on study at the discretion of the Principal Investigator.
  • Subjects who have had prior chemotherapy
  • Subjects who have had \>/=1 previous chemotherapy exposure resulting in alopecia
  • An existing history of scalp metastases or suspected presence of scalp metastasis
  • Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy
  • Previously received, or scheduled to undergo skull irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAlopecia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHypotrichosisHair DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Shari Goldfarb, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 27, 2019

Study Start

November 26, 2019

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(1)