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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least ā„ 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 ā„ 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.
What they're measuring
1
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA