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

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Updated on 14 May 2022

See if I qualify

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 Identifier	NCT04630080
Sponsor	Chinese University of Hong Kong
Last Modified on	14 May 2022

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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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Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients