Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05533320
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent of the participant
* Age: \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Ability to read and understand English or Spanish for questionnaires
* Documented diagnosis of metastatic breast cancer with at least a 6 month life expectancy
* A planned course of taxane based chemotherapy in the metastatic setting, including paclitaxel, docetaxel or abraxane
* At least 6 months from the last chemotherapy causing hair loss with complete recovery of hair
* Willing to be contacted for brief annual assessments for five years
* Women of childbearing potential (WOCBP): negative urine pregnancy test
* Agreement by females of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria:
* Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss
* A history of whole brain radiation with persistent hair thinning or alopecia, or concurrent whole brain radiation therapy
* Exposure to other investigational agents, drugs, device or procedure that may cause hair loss
* Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
* Any cutaneous scalp metastases
* Clinically significant liver dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
* Clinically significant renal dysfunction considered significant as determined by treating physician that would limit the patient's ability to administer the scalp cooling device
* A history of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
* Evidence of untreated or poorly controlled hyper or hypothyroidism
* American Society of Anesthesiologist Class \>= 3
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Pregnant or breastfeeding
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05533320
Study Brief:
Protocol Section:
NCT05533320