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 range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.)
. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
. Current and/or prior 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 grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens