Cooling cap may save hair for chinese breast cancer patients on chemo
NCT ID NCT04630080
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special cooling cap (Orbis Paxman system) to prevent hair loss in Chinese women with breast cancer undergoing chemotherapy. 25 participants will use the cap during chemo sessions. The goal is to see if it safely reduces hair loss and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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25 people
The number who actually took part.
- Started
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Jan 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, 852, Hong Kong
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Other studies related to the condition(s) this trial covers.
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