Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Chinese University of Hong Kong
Updated on 14 May 2022
paclitaxel
cyclophosphamide
fluorouracil
carboplatin
pertuzumab
docetaxel
trastuzumab
taxane
epirubicin
adjuvant chemotherapy
breast cancer staging
adriamycin

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.

Details
Condition Breast Cancer
Treatment Scalp cooling, Scalp cooling
Clinical Study IdentifierNCT04630080
SponsorChinese University of Hong Kong
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

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) >
AC x 4 cycles, followed by Docetaxel 100 mg/m2 for 4 cycles (AC-D)
-Fluorouracil 500 mg/m2, Epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2 for
cycles, followed by Docetaxel 100 mg/m2 for 3 cycles (FEC-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

ii) Subjects with cold agglutinin disease or cold urticaria
i) Subjects with any other concurrent malignancy including hematological malignancies (i.e
leukemia or lymphoma)
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
vi) Serum Albumin < 3.0
study at the discretion of the Principal Investigator
vii) Subjects with anemia (defined as a hemoglobin < 10)
v) Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
ix) Subjects who are underweight (defined as a BMI < 18.5)
viii) Subjects who have lichen planus or lupus, or other dermatological conditions
x) Subjects who have had previous chemotherapy exposure
involving scalp
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