Breast CancerNCT04630080
Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients
A study testing Scalp cooling in people with Breast Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Scalp cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of breast cancer stage I-III
- Chinese ethnicity
- ECOG 0-1
- Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
- 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:
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- 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.
- 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
Who cannot join
- Subjects with any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
- Subjects with cold agglutinin disease or cold urticaria
- Age ≥ 70 years
- 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.
- Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
- Serum Albumin < 3.0
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- Subjects with anemia (defined as a hemoglobin < 10)
- Subjects who have lichen planus or lupus, or other dermatological conditions involving scalp
- Subjects who are underweight (defined as a BMI < 18.5)
- Subjects who have had previous chemotherapy exposure
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, 852
About this study
Official title: Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients
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.
- Conditions
- Breast Cancer
- Being tested
- Scalp cooling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp coolingDevice
Scalp cooling is a physical method to reduce chemotherapy-induced alopecia
| Study group | Role | What they receive |
|---|---|---|
| Scalp Cooling | Experimental | Not described Receives: Device: Scalp cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of scalp cooling in preventing chemotherapy-induced alopecia
Measured: 2 year
Secondary outcomes (4)
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
Measured: 2 years
The quality of life during and after completion of chemotherapy
It will be assessed by study tool EORTC QLQ-30
Measured: 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
Measured: 2 years
The incidence of treatment-emergent adverse events of scalp cooling
It will be assessed by COMFORT SCALE FORM.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start8 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie Yeo, Chinese University of Hong Kong
- Investigators
- Winnie Yeo, MD, FRCP, Principal investigator, Department of Clinical Oncology, Prince of Wales Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630080
- Sponsor's protocol ID
- SYM013
- Status last verified
- Jan 2026
- First submitted
- 21 Oct 2020
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04630080
- Acronym / sponsor ID
- SYM013
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp Cooling | Experimental | Device: Scalp cooling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- New diagnosis of breast cancer stage I-III
- Chinese ethnicity
- ECOG 0-1
- Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
- Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline and/or taxane based chemotherapy regimen,
Key exclusion criteria (10 listed)
- Subjects with any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
- Subjects with cold agglutinin disease or cold urticaria
- Age ≥ 70 years
- 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.
- Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp coolingScalp cooling is a physical method to reduce chemotherapy-induced alopecia | Device | Scalp Cooling |
Primary outcome
The success rate of scalp cooling in preventing chemotherapy-induced alopecia
Time frame: 2 year
4 secondary outcomes
The rate of preceived hair preservation during and after completion of chemotherapy
Time frame: 2 years
The quality of life during and after completion of chemotherapy
Time frame: 2 years
The disease site specific quality of life during and after completion of chemotherapy
Time frame: 2 years
The incidence of treatment-emergent adverse events of scalp cooling
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winnie Yeo, MD, FRCP principal investigator
Department of Clinical Oncology, Prince of Wales Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp cooling in people with Breast Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of scalp cooling in preventing chemotherapy-induced alopecia (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.