Back to results

Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

Primary Purpose

Breast Cancer

Status

Active

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Scalp cooling

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Department of Clinical Oncology, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scalp Cooling

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

The quality of life during and after completion of chemotherapy

It will be assessed by study tool EORTC QLQ-30

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

It will be assessed by study tool EORTC QLQ - BR23

The incidence of treatment-emergent adverse events of scalp cooling

It will be assessed by COMFORT SCALE FORM.

Full Information

NCT ID

NCT04630080

First Posted

October 21, 2020

Last Updated

April 20, 2023

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT04630080

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scalp Cooling

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Scalp cooling

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 year

Secondary Outcome Measure Information:

Title

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

Description

It will be assessed by study tool ALOPECIA ASSESSMENT BY PATIENT AND WIG USE FORM

Time Frame

2 years

Title

The quality of life during and after completion of chemotherapy

Description

It will be assessed by study tool EORTC QLQ-30

Time Frame

2 years

Title

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

Description

It will be assessed by study tool EORTC QLQ - BR23

Time Frame

2 years

Title

The incidence of treatment-emergent adverse events of scalp cooling

Description

It will be assessed by COMFORT SCALE FORM.

Time Frame

2 years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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, 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winnie Yeo, MD, FRCP

Organizational Affiliation

Department of Clinical Oncology, Prince of Wales Hosptial

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Oncology, Prince of Wales Hospital

City

Hong Kong

ZIP/Postal Code

852

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

We'll reach out to this number within 24 hrs