Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients

The Orbis Paxman Hair Loss Prevention System is a new equipment introduced to Hong Kong in 2017. Although this device has been widely used in the United States, Europe and Australia, acceptability, efficacy and safety data in Chinese have not yet been available. The objective of this prospective study is to collect clinical data in Chinese patients using the Orbis Paxman Hair Loss Prevention System to prevent chemotherapy-induced alopecia.

This project seeks to demonstrate that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Scalp cooling

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 852
    • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

i) New diagnosis of breast cancer stage I-III

ii) Chinese ethnicity

iii) ECOG 0-1

iii) Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

iv) Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline and/or taxane based chemotherapy regimen,

1. Defined as one of the following regimens:

   • Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2 for 4 cycles (AC) > 5-Fluorouracil 500 mg/m2, Epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2 for 3 cycles, followed by Docetaxel 100 mg/m2 for 3 cycles (FEC-D)
   • AC x 4 cycles, followed by Docetaxel 100 mg/m2 for 4 cycles (AC-D)
   • AC x 4 cycles, followed by Paclitaxel 175 mg/m2 for 4 cycles (AC-P)
   • Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2 for 4-6 cycles (DC)
   • Docetaxel 75 mg/m2 with carboplatin AUC of 5-6 for 4-6 cycles (DCb)
2. Concurrent trastuzumab and/or pertuzumab at standard doses is allowed.
3. Administration of chemotherapy on a dose dense schedule with GCSF is allowed.

v) Adequate organ functions vi) Normal thyroid stimulating hormone vii) Subjects with history of diabetes must have acceptable HBA1c on study entry viii) Subjects who provide consent and are mentally competent and able to fill in study questionnaires

Exclusion Criteria:

i) Subjects with any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)

ii) Subjects with cold agglutinin disease or cold urticaria

iii) Age ≥ 70 years

iv) 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.

v) Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal

vi) Serum Albumin < 3.0

vii) Subjects with anemia (defined as a hemoglobin < 10)

viii) Subjects who have lichen planus or lupus, or other dermatological conditions involving scalp

ix) Subjects who are underweight (defined as a BMI < 18.5)

x) Subjects who have had previous chemotherapy exposure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scalp Cooling	Device: Scalp cooling; Scalp cooling is a physical method to reduce chemotherapy-induced alopecia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of scalp cooling in preventing chemotherapy-induced alopecia	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of preceived hair preservation during and after completion of chemotherapy	It will be assessed by study tool ALOPECIA ASSESSMENT BY PATIENT AND WIG USE FORM	2 years
The quality of life during and after completion of chemotherapy	It will be assessed by study tool EORTC QLQ-30	2 years
The disease site specific quality of life during and after completion of chemotherapy	It will be assessed by study tool EORTC QLQ - BR23	2 years
The incidence of treatment-emergent adverse events of scalp cooling	It will be assessed by COMFORT SCALE FORM.	2 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Winnie Yeo, MD, FRCP, Department of Clinical Oncology, Prince of Wales Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: SYM013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No