Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03289364
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2017-09-18
Brief Title:
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 neoadjuvant 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None