NCT04168242

Scalp Cooling in Gynecologic Cancer Patients

The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gynecologic Cancer
• Chemotherapy-Induced Change

Interventions

Type	Name	Description
DEVICE	Scalp cooling Paxman Orbis II system	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.
OTHER	Standard treatment	The control arm will not have scalp cooling before, during and after chemotherapy.

Timeline

• Start date: 2019-11-11
• Primary completion: 2023-01-30
• Completion: 2023-09-30
• First posted: 2019-11-19
• Last updated: 2023-12-20

Locations

1 site across 1 country: Hong Kong