Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05533320
Brief Summary:
This clinical trial evaluates the benefits of a portable scalp cooling system (PSCS) for improving chemotherapy-induced hair loss in patients with breast cancer that has spread to other places in the body (metastatic) and are undergoing taxane-based chemotherapy. The PSCS is a new system designed to reduce chemotherapy induced hair loss. The PSCS is designed as a portable unit, allowing patients to leave the infusion center after chemotherapy is completed and finish scalp cooling at home. PSCS may help improve chemotherapy-induced hair loss in patients with metastatic breast cancer receiving chemotherapy.
Detailed Description:
PRIMARY OBJECTIVE:
I. Measure efficacy of scalp cooling for patients undergoing taxane based chemotherapy for metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Assess safety of PSCS in treating patients with metastatic breast cancer. II. Assess burden on nurses and infusion center team of patients using the PSCS.
III. Assess tolerability of PSCS. IV. Assess hair loss and recovery as assessed by the patient. V. Assess patient quality of life and satisfaction with treatment.
OUTLINE:
Patients undergo scalp cooling using the PSCS 30 minutes before, during, and for up to 2 hours after completion of chemotherapy for 6 chemotherapy sessions.
After completion of study, patients are followed up for 1 year.
Study:
NCT05533320
Study Brief:
Protocol Section:
NCT05533320