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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03289364
• Other study ID #: 2017000277
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: September 2020
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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.

Locations

Country	Name	City	State
United States	Providence Cancer Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Providence Health & Services	Medical Specialties of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deans Alopecia Scale	Number of patients who score from 0-2 on Deans Alopecia Scale	30 days post chemotherapy treatment
Secondary	Was it Worth it Questionnaire	Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.	30 days post chemotherapy treatment
Secondary	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30	Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30	30 days post chemotherapy treatment
Secondary	Body Image Scale Questionnaire	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	30 days post chemotherapy treatment
Secondary	Common Terminology Criteria for Adverse Events (CTCAE) v4.0	The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale	30 days post chemotherapy treatment