Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

NCT04630080 | Active Not Recruiting

• 1 other identifier: SYM013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The success rate of scalp cooling in preventing chemotherapy-induced alopecia

  2 year

Secondary Outcomes (4)

• The rate of preceived hair preservation during and after completion of chemotherapy

  2 years

• The quality of life during and after completion of chemotherapy

  2 years

• The disease site specific quality of life during and after completion of chemotherapy

  2 years

• The incidence of treatment-emergent adverse events of scalp cooling

  2 years

Study Arms (1)

Scalp Cooling

EXPERIMENTAL

Device: Scalp cooling

Interventions

Scalp cooling DEVICE

Scalp cooling is a physical method to reduce chemotherapy-induced alopecia

Scalp Cooling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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)
• Concurrent trastuzumab and/or pertuzumab at standard doses is allowed.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, 852, Hong Kong

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Winnie Yeo, MD, FRCP

  Department of Clinical Oncology, Prince of Wales Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Clinical Oncology

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 16, 2020
• Study Start: January 8, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)