Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

• ClinicalTrials.gov Identifier: NCT03289364
• Recruitment Status: Unknown
• First Posted: September 20, 2017
• Last Update Posted: September 16, 2020
• Sponsor: Providence Health & Services
• Collaborator: Medical Specialties of California
• Information provided by (Responsible Party): Providence Health & Services

Tracking Information

• First Submitted Date: September 18, 2017
• First Posted Date: September 20, 2017
• Last Update Posted Date: September 16, 2020
• Actual Study Start Date: August 24, 2017
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2017)

Deans Alopecia Scale [ Time Frame: 30 days post chemotherapy treatment ]

Number of patients who score from 0-2 on Deans Alopecia Scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 19, 2017)

• Was it Worth it Questionnaire [ Time Frame: 30 days post chemotherapy treatment ]
  Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.
• European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 [ Time Frame: 30 days post chemotherapy treatment ]
  Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30
• Body Image Scale Questionnaire [ Time Frame: 30 days post chemotherapy treatment ]
  These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire
• Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: 30 days post chemotherapy treatment ]
  The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
• Official Title: A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer
• Brief Summary: The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.

Detailed Description

This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy.

Eligible subjects will be enrolled to one of 4 study arms (Table 5) determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).

The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: Breast Cancer

Intervention

Device: Penguin Cold Caps

Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.

Study Arms

Experimental: Penguin Cold Caps

Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.

Intervention: Device: Penguin Cold Caps

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 8, 2019): 9
• Original Estimated Enrollment (submitted: September 19, 2017): 80
• Estimated Study Completion Date: January 1, 2023
• Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At least ≥ 18 years of age
• Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.
• Willing and able to provide informed consent.
• Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique.
• Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy.

Exclusion Criteria:

• Pre-existing alopecia (Dean's scale ≥ 1)
• Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment.
• Prior radiotherapy treatment involving head.
• Pre-existing chronic severe headaches or migraines.
• Skin conditions that in the opinion of PI would be at risk of worsening with study.
• Cold sensitivity or cold agglutinin disease
• Cryoglobulinemia
• Cryofibrogenemia
• History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03289364
• Other Study ID Numbers: 2017000277
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Providence Health & Services
• Original Responsible Party: Same as current
• Current Study Sponsor: Providence Health & Services
• Original Study Sponsor: Same as current
• Collaborators: Medical Specialties of California

Investigators

• Principal Investigator: David Page, MD; Providence Health & Services

• PRS Account: Providence Health & Services
• Verification Date: September 2020