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NCT Number: NCT05508984

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Providence Cancer Institute - Newberg Clinic, Newberg, Oregon, United States

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About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Amma Cooling Caps

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • Cooler Heads

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 19, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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