N/A
Completed N=12
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Source: ClinicalTrials.gov NCT03289364 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA — 4; 3; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA |
4; 3; 3 | — |
| SECONDARY "Was It Worth It?" Questionnaire Exit Interview |
9; 10; 8; 5; 5 | — |
| SECONDARY EORTC QLQ-C30 Exit Interview |
64.58; 84.17; 62; 69.79; 64.58; 70.84 | — |
| SECONDARY BR23 Exit Interview |
64.58; 41.67; 4.17 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03289364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.