Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients (NCT03289364) | Clinical Trial Compass
CompletedNot Applicable
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
United States12 participantsStarted 2017-08-24
Plain-language summary
The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.
Who can participate
Age range
18 Years
Sex
ALL
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:
* At least ≥ 18 years of age
* Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.
* Willing and able to provide informed consent.
* Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique.
* Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy.
Exclusion Criteria:
* Pre-existing alopecia (Dean's scale ≥ 1)
* Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment.
* Prior radiotherapy treatment involving head.
* Pre-existing chronic severe headaches or migraines.
* Skin conditions that in the opinion of PI would be at risk of worsening with study.
* Cold sensitivity or cold agglutinin disease
* Cryoglobulinemia
* Cryofibrogenemia
* History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.
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.
What they're measuring
1
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA