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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 : Recruiting
First Posted : September 20, 2017
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
Medical Specialties of California
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Penguin Cold Caps Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
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
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
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Deans Alopecia Scale [ Time Frame: 30 days post chemotherapy treatment ]
    Number of patients who score from 0-2 on Deans Alopecia Scale


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289364


Contacts
Contact: Larisa Lundgren (503) 215-2614 Larisa.Lundgren@Providence.org

Locations
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Contact: Nikki Moxon, RN    503-215-2619    nicole.moxon@providence.org   
Contact: Brenda Fisher, RN    503-215-2613    brenda.fisher@providence.org   
Sub-Investigator: Walter J. Urba, M.D., Ph.D         
Sub-Investigator: Rachel Sanborn, MD         
Sub-Investigator: Todd Crocenzi, MD         
Sub-Investigator: Rui Li, MD, PhD         
Sub-Investigator: Rom Leidner, MD         
Sub-Investigator: Brendan Curti, MD         
Sub-Investigator: Alison Conlin, MD         
Sub-Investigator: John Godwin, MD         
Principal Investigator: David Page, MD         
Sub-Investigator: Anupama Acheson, MD         
Sub-Investigator: Nicholas Barber, MD         
Sub-Investigator: Regan Duffy, MD         
Sub-Investigator: Stacy Lewis, MD         
Sub-Investigator: Christine Lin, MD         
Sub-Investigator: Christie Moore, DO         
Sub-Investigator: Herschel Wallen, MD         
Sponsors and Collaborators
Providence Health & Services
Medical Specialties of California
Investigators
Principal Investigator: David Page, MD Providence Health & Services

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT03289364     History of Changes
Other Study ID Numbers: Study2017000277
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Providence Health & Services:
Breast Cancer
Alopecia
Hair Loss
Scalp Cooling
Penguin Cold Caps

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases