NCT04678544

Cooling Cap Trial to Prevent Permanent Chemotherapy-induced Alopecia in Breast Cancer Patients

Completed NA Last updated 5 November 2024

What this trial tests

NA trial testing Scalp cooling system 2 in Neoplasm, Breast in 170 participants. Completed in 30 August 2022.

Timeline

23 December 2020

Primary endpoint
27 August 2021

30 August 2022

Quick facts

Lead sponsor	Samsung Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	170
Start date	23 December 2020
Primary completion	27 August 2021
Estimated completion	30 August 2022
Sites	1 location across South Korea

Drugs / interventions tested

• Scalp cooling system 2

Conditions studied

• Neoplasm, Breast — all drugs for Neoplasm, Breast →

Sponsor

Samsung Medical Center

Who can join

Adults 20 to 69, female only, with Neoplasm, Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to examine whether the PSCS2 is effective in reducing chemotherapy-induced alopecia in women with breast cancer undergoing neoadjuvant or adjuvant chemotherapy. Female adults who are newly diagnosed with stage 1-3 breast cancer and expected to receive Adriamycin or/Taxane will participate in the study. The study design is an open-label, randomized controlled trial. The patients will be randomly assigned to intervention or control groups. Intervention patients will have applied scalp cooling during 4 or 6 cycles of their chemotherapy. The primary endpoint is the effectiveness of the PSCS2 for reducing permanent chemotherapy-induced alopecia. Secondary endpoints include chemotherapy-induced alopecia, distress due to chemotherapy-induced alopecia, quality of life, and patient-reported alopecia-related side effects.

After the RCT, only patients who were expected to receive 4, 6, or 8 cycles of chemotherapy with an anthracycline regimen were further enrolled in the intervention group as a single-arm trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prevention and Treatment of Chemotherapy-Induced Alopecia: What Is Available and What Is Coming?
   Wikramanayake TC, Haberland NI, Akhundlu A, Laboy Nieves A, et al · · 2023 · cited 37× · PMID 37185388 · DOI 10.3390/curroncol30040275