Clinical trial · Interventional
Scalp Cooling in Gynecologic Cancer Patients
The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
NCT04168242CI-TRIAL-00072435completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Change | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scalp cooling Paxman Orbis II system | Device | — | UNRESOLVED |
| Standard treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Patients have scalp cooling during the chemotherapy period
- interventionNames
- Device: Scalp cooling Paxman Orbis II system
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- Patients do not have scalp cooling during the chemotherapy period
- interventionNames
- Other: Standard treatment
Primary outcomes (1)
- measure
- Incidence and grading of chemotherapy induced alopecia
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be at least 18 years old. 2. Patients with primary gynecologic cancers. 3. Patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide. 4. Patients who are fit to give informed consent. Exclusion Criteria: 1. Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded. 2. Patients who have the following conditions will be excluded: 1. migraine 2. scalp or brain metastasis 3. hypothyroidism 4. uncontrolled diabetes 5. liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit) 6. severe untreated anaemia 7. cold sensitivity 8. cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia 3. Patients who had brain irradiation. 4. Patients who have documented psychiatric disorders will be excluded. 5. Patients who are pregnant.
References
Publications (1)
- DERIVEDKwok 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. PMID 41851427