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In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.
Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients have scalp cooling during the chemotherapy period |
|
| Control arm | Placebo Comparator | Patients do not have scalp cooling during the chemotherapy period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalp cooling Paxman Orbis II system | Device | The experimental arm will have scalp cooling that starts 30 minutes before the chemotherapy, continues throughout the infusion of the chemotherapy, and lasts for 20-90 minutes more depending on the type of regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and grading of chemotherapy induced alopecia | Will be assessed by Dean's scale Grade 0 - 4 (from 0% to >75% hair loss) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-life scale | Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is. | 9 months |
| Anxiety / depression level |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
Patients who have the following conditions will be excluded:
Patients who had brain irradiation.
Patients who have documented psychiatric disorders will be excluded.
Patients who are pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Ka Yu Tse | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41851427 | Derived | Kwok ST, Lau LSK, Chan TO, Chu MMY, Ngu SF, Chan KKL, Ngan HYS, Ho PPY, Wu L, Hung DSM, Lo HKY, Wong CSM, Tse KY. The efficacy of scalp cooling in patients receiving chemotherapy for primary gynecologic cancers: a randomized controlled trial. Sci Rep. 2026 Mar 18;16(1):14109. doi: 10.1038/s41598-026-44772-2. |
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| Standard treatment | Other | The control arm will not have scalp cooling before, during and after chemotherapy. |
|
Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is. |
| 9 months |
| Incidence and grading of treatment-related adverse events | Will be assessed by CTCAE v5.0 | 9 months |