Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads) (NCT06215469) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
United States40 participantsStarted 2024-05-16
Plain-language summary
The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
✓. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
✓. Plan to complete the current CT regimen within six months.
✓. 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.
✓. At least two years out from the last CT causing hair loss with complete recovery of hair.
✓. Age \>=21 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status of \<=1.
✓. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
✕. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale.
. 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 (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)
✕. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
✕. Concurrent use of hair growth products, such as Nutrafol, minoxidil, and Keranique.
✕. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up.
✕. History of persistent alopecia (any grade) induced by prior chemotherapeutic regimens.