Trial Outcomes & Findings for Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients (NCT NCT03289364)
NCT ID: NCT03289364
Last Updated: 2026-04-28
Results Overview
Efficacy will be reported as the proportion of evaluable subjects in each arm who achieve a score of 0-2 on the Dean's alopecia scale (i.e. less than 50% hair loss by standardized photography) at the 30-day post-chemotherapy assessment visit. A modified intention-to-treat (ITT) analysis will be followed whereby all subjects receiving at least 75% of prescribed chemotherapy dose will be considered evaluable (those receiving less chemotherapy are excluded to minimize confounding effect of chemotherapy dose). Subjects who withdraw consent prior to efficacy assessment will constitute treatment failures according to the intention-to-treat principle. Dean's alopecia scale is as follows: Grade 0 indicates no hair loss, Grade 1 indicates up to 25% hair loss, Grade 2 indicates greater than 25% hair loss up to 50% hair loss, Grade 3 indicates greater than 50% hair loss up to 75% hair loss, and Grade 4 indicates greater than 75% hair loss.
COMPLETED
NA
12 participants
30 days post chemotherapy treatment
2026-04-28
Participant Flow
Slow accrual and exhausted funding led to only 12 patients enrolled instead of the planned 20.
Participant milestones
| Measure |
Penguin Cold Caps
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Penguin Cold Caps
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Penguin Cold Caps
n=10 Participants
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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Age, Continuous
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49 years
n=9 Participants
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Sex: Female, Male
Female
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10 Participants
n=9 Participants
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Sex: Female, Male
Male
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0 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=9 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=9 Participants
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Region of Enrollment
United States
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10 participants
n=9 Participants
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Menopausal Status
Pre-Menopausal
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6 Participants
n=9 Participants
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Menopausal Status
Post-Menopausal
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2 Participants
n=9 Participants
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Menopausal Status
Unknown
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2 Participants
n=9 Participants
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Chemotherapy Setting
Adjuvant
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4 Participants
n=9 Participants
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Chemotherapy Setting
Neoadjuvant
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6 Participants
n=9 Participants
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Hair Thickness
Fine
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3 Participants
n=9 Participants
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Hair Thickness
Medium
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4 Participants
n=9 Participants
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Hair Thickness
Thick
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3 Participants
n=9 Participants
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PRIMARY outcome
Timeframe: 30 days post chemotherapy treatmentEfficacy will be reported as the proportion of evaluable subjects in each arm who achieve a score of 0-2 on the Dean's alopecia scale (i.e. less than 50% hair loss by standardized photography) at the 30-day post-chemotherapy assessment visit. A modified intention-to-treat (ITT) analysis will be followed whereby all subjects receiving at least 75% of prescribed chemotherapy dose will be considered evaluable (those receiving less chemotherapy are excluded to minimize confounding effect of chemotherapy dose). Subjects who withdraw consent prior to efficacy assessment will constitute treatment failures according to the intention-to-treat principle. Dean's alopecia scale is as follows: Grade 0 indicates no hair loss, Grade 1 indicates up to 25% hair loss, Grade 2 indicates greater than 25% hair loss up to 50% hair loss, Grade 3 indicates greater than 50% hair loss up to 75% hair loss, and Grade 4 indicates greater than 75% hair loss.
Outcome measures
| Measure |
Penguin Cold Caps
n=10 Participants
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
Dean's score 0
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4 Participants
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Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
Dean's score 1
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3 Participants
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Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
Dean's score 2
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3 Participants
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SECONDARY outcome
Timeframe: 30 days post chemotherapy treatmentPatient reported outcomes (PROs) will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial for the WIWI scale.
Outcome measures
| Measure |
Penguin Cold Caps
n=10 Participants
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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"Was It Worth It?" Questionnaire Exit Interview
Study participation was worthwhile
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9 participants
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"Was It Worth It?" Questionnaire Exit Interview
Recommended to others
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10 participants
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"Was It Worth It?" Questionnaire Exit Interview
Worth repeat participation
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8 participants
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"Was It Worth It?" Questionnaire Exit Interview
Subjects reporting improved quality of life (QOL)
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5 participants
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"Was It Worth It?" Questionnaire Exit Interview
Better experience than expected
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5 participants
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SECONDARY outcome
Timeframe: 30 days post chemotherapy treatmentPopulation: Eight subjects participated in the optional exit interview.
Optional patient reported outcomes (PROs) for European Organization for Research and Treatment of Cancer: Quality of Life Core-30 (EORTC QLQ-C30), version 3.0. The EORTC QLQ-C30 covers five functional scales and three symptom scales. Scores range from 0 to 100 with higher scores indicate a better quality of life/outcome 30 days post chemotherapy treatment.
Outcome measures
| Measure |
Penguin Cold Caps
n=8 Participants
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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EORTC QLQ-C30 Exit Interview
Functional Scale: Social
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70.84 score on a scale
Standard Deviation 26.3
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EORTC QLQ-C30 Exit Interview
Symptom Scale: Financial Difficulties
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33.33 score on a scale
Standard Deviation 39.8
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EORTC QLQ-C30 Exit Interview
Global Health Status
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64.58 score on a scale
Standard Deviation 19.8
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EORTC QLQ-C30 Exit Interview
Functional Scale: Physical
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84.17 score on a scale
Standard Deviation 16.3
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EORTC QLQ-C30 Exit Interview
Functional Scale: Role
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62 score on a scale
Standard Deviation 21.7
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EORTC QLQ-C30 Exit Interview
Functional Scale: Emotional
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69.79 score on a scale
Standard Deviation 24.8
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EORTC QLQ-C30 Exit Interview
Functional Scale: Cognitive
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64.58 score on a scale
Standard Deviation 22.6
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SECONDARY outcome
Timeframe: 30 days post chemotherapyPopulation: 8 of the 10 patients participated in the optional exit interview.
Patient reported outcome (PRO) using the European Organization for Research and Treatment of Cancer: Quality of Life Breast Cancer Module (EORTC QLQ-BR23) and body image scale (BIS). For the QLQ-BR23, scores range from 0 to 100, with higher scores indicating better quality of life for patients. For the BIS, scores range from 0 to 30, with a higher score indicating a higher level of body image disturbance.
Outcome measures
| Measure |
Penguin Cold Caps
n=8 Participants
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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BR23 Exit Interview
Functional Scales (BR23): Body Image
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64.58 score on a scale
Standard Deviation 21.7
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BR23 Exit Interview
Functional Scales (BR23): Future Perspective
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41.67 score on a scale
Standard Deviation 29.6
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BR23 Exit Interview
Symptom Scale (BIS): Upset by Hair Loss
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4.17 score on a scale
Standard Deviation 23.5
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Adverse Events
Penguin Cold Caps
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Penguin Cold Caps
n=10 participants at risk
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Penguin Cold Caps: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
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|---|---|
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Skin and subcutaneous tissue disorders
Head Sore
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10.0%
1/10 • Number of events 1 • 11 months
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Nervous system disorders
Headache
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20.0%
2/10 • Number of events 2 • 11 months
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Gastrointestinal disorders
Nausea
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90.0%
9/10 • Number of events 9 • 11 months
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Nervous system disorders
Syncope
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10.0%
1/10 • Number of events 1 • 11 months
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Gastrointestinal disorders
Vomiting
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20.0%
2/10 • Number of events 3 • 11 months
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Additional Information
Dr. David B. Page
Earle A. Chiles Research Institute, Providence Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place