Clinical trial NCT04630080: Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients
Official title: Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The success rate of scalp cooling in preventing chemotherapy-induced alopecia
timeFrame: 2 year
Secondary outcomes:
measure: The rate of preceived hair preservation during and after completion of chemotherapy
timeFrame: 2 years
measure: The quality of life during and after completion of chemotherapy
timeFrame: 2 years
measure: The disease site specific quality of life during and after completion of chemotherapy
timeFrame: 2 years
measure: The incidence of treatment-emergent adverse events of scalp cooling
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hosptial
name: Winnie Yeo, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: