Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss (NCT05484973) | Clinical Trial Compass
RecruitingNot Applicable
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
United States99 participantsStarted 2024-11-08
Plain-language summary
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.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. 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
✓. Plan to complete the current CT regimen within six months
✓. At least two years out from the last CT causing hair loss with complete recovery of hair
✓. Karnofsky17 performance status 80% or greater
✓. Willing and able to sign informed consent for this study
Exclusion criteria
✕. 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.)