Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Scalp cooling


Participation Criteria
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Eligibility Criteria
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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, 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp Cooling<br> | Device: Scalp cooling<br>* Scalp cooling is a physical method to reduce chemotherapy-induced alopecia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |