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New treatment option for Alopecia
Official title Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
ClinicalTrials.gov ID: NCT05484973
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older, women only
You may be able to join if
- 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...
- Plan to complete the current CT regimen within six months
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- Willing and able to complete all required study procedures
- 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
- History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
- Cold sensitivity
- Intercurrent life-threatening malignancy
- Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
- History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- Concurrent hematologic malignancy
- Participation in any other clinical investigation
- Concurrent treatment with any investigational agent
- Any reason the investigator does not believe the patient is a good candidate for the study
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Urbana, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Urbana, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.