Clinical trial · Interventional
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Single-site study, site was unable to participate
Summary
Brief summary (as posted)
Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Alopecia | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Hair Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMMA Portalbe Scalp Cooling System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- All patients will use AMMA
- interventionNames
- Device: AMMA Portalbe Scalp Cooling System
Primary outcomes (3)
- measure
- Compliance with AMMA use
- timeFrame
- 6 months
- description
- Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
- measure
- Experience of AMMA use
- timeFrame
- 6 months
- description
- Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding ease of product setup and use in the clinic, during the ride home and at home
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female age 21 years or older at the time of signing informed consent. * Documented pathologic diagnosis of invasive breast or gynecologic cancer, any stage, requiring treatment with a taxane-containing chemotherapy regimen * Planned start of treatment with taxane-based chemotherapy in the adjuvant, neoadjuvant or advanced setting * Plan to complete chemotherapy within 6 months of treatment start * If received prior chemotherapy causing hair loss, \>/= 2 years since last chemotherapy dose and complete recovery of hair * ECOG performance status 0-1 * Willing and able to sign informed consent for study procedures * Willing and able to participate in all study procedures Exclusion Criteria: * Plan to use chemotherapy regimen other than that listed in inclusion criteria, including any anthracycline-based regimen * Plan to initiate bone marrow ablation chemotherapy * History of or plan to initiate whole or partial brain or skull irradiation * Hormone therapy concurrent with current chemotherapy regimen * Existing or suspected scalp metastases * History of concomitant diagnosis of: autoimmune disease affecting hair; cryoglobulinemia; untreated iron deficiency with or without anemia; cold agglutination disease; post-traumatic cold dystrophy; untreated or poorly controlled hyper- or hypothyroidism * Female pattern baldness * History of persistent chemotherapy-induced alopecia from prior chemotherapy * Concomitant exposure to investigational agents, drugs, devices or procedures that cause hair loss * Concomitant other solid tumor or hematologic malignancy in addition to the current diagnosis
References
Publications (0)
Data not yet available