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

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ClinicalTrials.gov Identifier: NCT03289364
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Medical Specialties of California
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date  ICMJE September 18, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE August 24, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Breast Cancer
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2017)
80
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289364
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor  ICMJE Providence Health & Services
Collaborators  ICMJE Medical Specialties of California
Investigators  ICMJE
Principal Investigator: David Page, MD Providence Health & Services
PRS Account Providence Health & Services
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP