To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Outcomes and Patient Satisfaction With Use of the Amma System
NCT ID:
NCT05508984
Condition:
Breast Cancer
Conditions: Keywords:
Amma, Cooler Heads
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Amma Cooling Caps
Description:
Once enrolled, subjects will be provided the Amma device by the clinic on days of
chemotherapy treatment, and upon completion of treatment it will be returned to the
clinic for safekeeping. Upon completion of chemotherapy, anywhere from 3-6 weeks
following treatment, subjects will repeat the questionnaires and their hair will be
photographed again.
The overall duration of the study for subjects will be anywhere from 4 months to 8
months, depending on the duration of their chemotherapy regimen.
Arm group label:
Single Arm
Summary:
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Women with stage I-III breast cancer are eligible to participate if they have a
curative-intent chemotherapy regimen.
Sampling method:
Non-Probability Sample
Criteria:
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)
Gender:
Female
Gender based:
Yes
Gender description:
Women with stage I-III breast cancer are eligible to participate.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Providence Cancer Institute - Newberg Clinic
Address:
City:
Newberg
Zip:
97132
Country:
United States
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Facility:
Name:
Providence Oncology and Hematology Care - Westside
Address:
City:
Portland
Zip:
97225
Country:
United States
Start date:
August 22, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Providence Health & Services
Agency class:
Other
Collaborator:
Agency:
Cooler Heads
Agency class:
Other
Source:
Providence Health & Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508984
