Language: BG BG
← Back to results
Active (not recruiting) NCT05508984

Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Conditions: Breast Cancer

Sponsor: Providence Health & Services

trial.available_in: БГ
Overview
The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH\&S system.
Description
A novel cold capping device, named Amma™, is now commercially available for use and FDA approved. The Amma system has the potential to be as effective as the Penguin Cold Cap system, but with key innovations that make it more efficient and feasible in the clinic. Innovations include: * Portable and battery powered unit, not requiring dry ice * Form-fitting scalp cap that eliminates the need for frequent cap exchanges The Amma system has not been evaluated for efficacy, and no clinical trials are published. Because of the ease of use and the self-directed administration of the Amma scalp cooling device, we wish to explore this as an option for patients treated within the PH\&S system. To do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the Amma system.
Who can participate
Inclusion Criteria: \- Women with stage I-III breast cancer are eligible to participate if: * They consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews * They consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes * Curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: TC x 4, T x 12, TCHP x6)
Interventions
Amma Cooling Caps
DEVICE
Locations 3
United States (3)
Providence Cancer Institute - Newberg Clinic
Newberg , Oregon
Providence Portland Medical Center
Portland , Oregon
Providence Oncology and Hematology Care - Westside
Portland , Oregon
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
22.08.2022
Completion date
01.12.2026
Registry ID
NCT05508984
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.