Clinical Outcomes and Patient Satisfaction With Use of the Amma System

April 21, 2026 updated by: Providence Health & Services

Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Newberg, Oregon, United States, 97132
        • Providence Cancer Institute - Newberg Clinic
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Oncology and Hematology Care - Westside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Arm

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.
Device: Amma Cooling Caps

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMMA Feasibility Within PH&S System
Time Frame: 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.
End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Utilizing Dean's Score
Time Frame: 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.
End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Patient Reported Outcome Utilizing Body Image Scale
Time Frame: 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.
End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Patient Satisfaction Utilizing the Was It Worth It Questionnaire
Time Frame: 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.
End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Collaborators

Cooler Heads

Investigators

  • Principal Investigator: David Page, MD, Providence Health & Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Actual)

January 24, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022000438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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