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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma

Intervention / Treatment
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* Device: Cold Cap Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented informed consent of the participant Age: >= 18 years Eastern Cooperative Oncology Group (ECOG) =< 2 Ability to read and understand English or Spanish for questionnaires Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair Willing to be contacted for brief annual assessments for five years Women of childbearing potential (WOCBP): negative urine pregnancy test Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only) Exclusion Criteria: Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy Exposure to other investigational agents, drugs, device or procedure that may cause hair loss Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale Any cutaneous scalp metastases Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens Evidence of untreated or poorly controlled hyper or hypothyroidism American Society of Anesthesiologist Class >= 3 Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures Pregnant or breastfeeding Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (PSCS)<br>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. | Device: Cold Cap Therapy<br>* Undergo scalp cooling<br>* Other names: Scalp Hypothermia;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 4 weeks after completion of the 6th chemotherapy cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | Up to 1 year | 
| Hair loss recovery | Patient self-assessment of hair loss at each chemotherapy infusion. | 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. | Up to 30 days after the last dose of treatment |