Clinical Outcomes and Patient Satisfaction With Use of the Amma System

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Device: Amma Cooling Caps

• Registration Number: NCT05508984
• Lead Sponsor: Providence Health & Services

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Study Start: 2022-08-22
• Primary Completion: 2024-01-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Amma Cooling Caps	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.

Primary Outcome Measures

Name	Time	Method
AMMA Feasibility Within PH&S System	End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)	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 with early-stage breast cancer within oncology suites within the PH\&S system. Patient satisfaction will be assessed using pre and post treatment questionnaires related to the Amma system and an exit interview.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Utilizing the Was It Worth It Questionnaire	End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)	Patient satisfaction will be assessed utilizing the Was It Worth It (WIWI) questionnaire.
Patient Reported Outcome Utilizing Dean's Score	End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)	Patient satisfaction will be assessed via alopecia assessment utilizing Deans Scale collected at baseline and at end of treatment.
Patient Reported Outcome Utilizing Body Image Scale	End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)	Patient satisfaction will be assessed utilizing the Body Image Scale (BIS) questionnaire.

Trial Locations

Locations (3)

Providence Cancer Institute - Newberg Clinic; 🇺🇸 Newberg, Oregon, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Providence Oncology and Hematology Care - Westside; 🇺🇸 Portland, Oregon, United States