Status:
UNKNOWN
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Medical Specialties of California
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sta...
Detailed Description
This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03289364
Start Date
August 24 2017
End Date
January 1 2023
Last Update
September 16 2020
Active Locations (1)
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1
Providence Cancer Center
Portland, Oregon, United States, 97213