Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorCooler Heads Care Inc.
About this trial
The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.
Eligibility criteria
Qualifiers
Female patients ≥ 21 years of age
Documented diagnosis of breast cancer, stage I, II, or III
A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period
Disqualifiers
Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
A history of whole brain radiation
Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.)
Trial design
Treatments tested in this trial
- AMMA Portalbe Scalp Cooling System
Treatment groups
99 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov