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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Success in hair preservation
Hair loss will be measured by the patient according to the Dean Score. (Grade 0: no hair loss, grade 1: \> 0 - 25%; grade 2: \> 25 - 50%; grade 3: \> 50 - 75%; grade 4: \> 75%). Hair preservation was defined as hair loss no more than grade 2.
Time frame: At 4 weeks after completion of the 6th chemotherapy cycle
Incidence of adverse events of PSCS
Will be determined by spontaneous reporting of adverse events and negative scalp changes determined by physical examination. Frequency tables will be used to summarize these events.
Time frame: At 4 weeks, 3 months, and 6 months following the conclusion of 6 cycles of chemotherapy
Burden on nurses and infusion center team
The workload impact will be assessed via surveys distributed to nurses, and descriptive analysis will be used to explore the collected data.
Time frame: Up to 1 year
Tolerability of PSCS
Will be determined by the proportion of patients who completed all planned cycles of chemotherapy using the PSCS will be assessed (including 95% CI).
Time frame: Up to 1 year
Hair loss recovery
Patient self-assessment of hair loss at each chemotherapy infusion.
Time frame: Up to 1 year
Patients quality of life
Will be measured by EORTC-QLQ-30 quality of life questionnaire. Changes will be summarized descriptively and comparison with baseline will be carried out using paired t-test (or non-parametric paired test when suitable). In addition, repeated measures one-way ANOVA will also be used where appropriate to evaluate changes over time.
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Time frame: Up to 30 days after the last dose of treatment