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Cooling cap may save hair for chinese breast cancer patients on chemo

NCT ID NCT04630080

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

25 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

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

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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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

  • Department of Clinical Oncology, Prince of Wales Hospital

    Hong Kong, 852, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.