NCT05533320

Portable Scalp Cooling System for the Improvement of Chemotherapy-Induced Hair Loss in Patients With Metastatic Breast Cancer

Evaluation Of Benefits of The Portable Scalp Cooling System (PSCS) in Metastatic Breast Cancer Patients on Taxane-Based Chemotherapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	Cold Cap Therapy	Undergo scalp cooling
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2022-09-09
• Last updated: 2023-02-02

Regulatory

• FDA-regulated device study