Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03289364|
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Penguin Cold Caps||Not Applicable|
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)|
|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|
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.
- Deans Alopecia Scale [ Time Frame: 30 days post chemotherapy treatment ]Number of patients who score from 0-2 on Deans Alopecia Scale
- 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
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
|Contact: Larisa Lundgren||(503) 215-2614||Larisa.Lundgren@Providence.org|
|United States, Oregon|
|Providence Cancer Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Nikki Moxon, RN 503-215-2619 firstname.lastname@example.org|
|Contact: Brenda Fisher, RN 503-215-2613 email@example.com|
|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|
|Principal Investigator:||David Page, MD||Providence Health & Services|