Breast CancerNCT05508984
Clinical Outcomes and Patient Satisfaction With Use of the Amma System
An observational study of Breast Cancer, run by Providence Health & Services at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Amma Cooling Caps
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Aug 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Providence Cancer Institute - Newberg Clinic
Newberg, Oregon, 97132
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Oncology and Hematology Care - Westside
Portland, Oregon, 97225
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Amma Cooling Caps
- Keywords
- Amma, Cooler Heads
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amma Cooling CapsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Amma Cooling Caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMMA Feasibility Within PH&S 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 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.
Measured: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Secondary outcomes (3)
Patient Reported Outcome Utilizing Dean's Score
Patient satisfaction will be assessed via alopecia assessment utilizing Deans Scale collected at baseline and at end of treatment.
Measured: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Patient Reported Outcome Utilizing Body Image Scale
Patient satisfaction will be assessed utilizing the Body Image Scale (BIS) questionnaire.
Measured: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Patient Satisfaction Utilizing the Was It Worth It Questionnaire
Patient satisfaction will be assessed utilizing the Was It Worth It (WIWI) questionnaire.
Measured: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start22 Aug 2022
- Primary completion24 Jan 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Cooler Heads
- Responsible party
- Sponsor
- Investigators
- David Page, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508984
- Sponsor's protocol ID
- 2022000438
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System
- ClinicalTrials.gov ID
- NCT05508984
- Acronym / sponsor ID
- 2022000438
- Conditions
- Breast Cancer
- Keywords
- Amma, Cooler Heads
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Cooler Heads
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: Amma Cooling CapsAnywhere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amma Cooling CapsOnce 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. | Device | Single Arm |
Primary outcome
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.
3 secondary outcomes
Patient Reported Outcome Utilizing Dean's Score
Time frame: 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 Utilizing the Was It Worth It Questionnaire
Time frame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Page, MD principal investigator
Providence Health & Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Providence Health & Services at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMMA Feasibility Within PH&S System (time frame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.