Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Providence Health & Services

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Device: Amma Cooling Caps

Study type: Observational

Funder types: Other

Identifiers

NCT05508984

2022000438

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

15 participants in 1 patient group

Single Arm

Description:

Anywhere from 14 to 0 days prior to treatment, enrolled subjects will complete the following questionnaires, and their hair will be photographed by research staff. 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. Subjects will then complete their enrollment in the study.

Treatment:

Device: Amma Cooling Caps