Clinical trial · Observational
Clinical Outcomes and Patient Satisfaction With Use of the Amma System
Observational Study of Clinical Outcomes and Patient Satisfaction With Use of the Amma System
NCT05508984CI-TRIAL-00109313active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amma Cooling Caps | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- 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.
- interventionNames
- Device: Amma Cooling Caps
Primary outcomes (1)
- measure
- AMMA Feasibility Within PH&S System
- timeFrame
- End of Treatment (4 to 8 months, depending on duration of their chemotherapy regimen)
- description
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.