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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Cold Cap Therapy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
      • Contact: James R. Waisman; Email: jwaisman@coh.org
      • Principal Investigator: James R. Waisman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (PSCS); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Device: Cold Cap Therapy; Undergo scalp cooling; Other Names: Cold Cap; Paxman Scalp Cooling System; PSCS; Scalp Cooling; Scalp Cryotherapy; Scalp Hypothermia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: James R Waisman, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 14, 2022
• Primary Completion (Anticipated): November 14, 2023
• Study Completion (Anticipated): November 14, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 21030 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-06837 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No