An observational study in Breast Cancer, sponsored by Providence Health & Services. Active, not recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Providence Health & Services · Observational
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.
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:
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 15 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Providence Health & Services is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with stage I-III breast cancer are eligible to participate if they have a curative-intent chemotherapy regimen.
Inclusion Criteria:
- Women with stage I-III breast cancer are eligible to participate if:
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.
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.
Time frame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
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.
Time frame: 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.
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
Patient satisfaction will be assessed utilizing the Was It Worth It (WIWI) questionnaire.
Time frame: End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Providence Health & Services