An interventional study of Penguin Cold Caps in Breast Cancer, sponsored by Providence Health & Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Providence Health & Services · Not applicable, Interventional, and Prevention
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.
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 alopecia in patients with early stage breast cancer undergoing chemotherapy.
Eligible subjects will be enrolled to one of 4 study arms determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).
The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.
Exclusion Criteria:
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
Device: 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.
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
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.
Time frame: 30 days post chemotherapy treatment
"Was It Worth It?" Questionnaire Exit Interview
Patient 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.
Time frame: 30 days post chemotherapy treatment
EORTC QLQ-C30 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.
Time frame: 30 days post chemotherapy treatment
BR23 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.
Time frame: 30 days post chemotherapy
| Milestone | Penguin Cold Caps |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Participants | Penguin Cold Caps |
|---|---|
| Dean's score 0 | 4 |
| Dean's score 1 | 3 |
| Dean's score 2 | 3 |
Patient 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.
| participants | Penguin Cold Caps |
|---|---|
| Study participation was worthwhile | 9 |
| Recommended to others | 10 |
| Worth repeat participation | 8 |
| Subjects reporting improved quality of life (QOL) | 5 |
| Better experience than expected | 5 |
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.
| score on a scale | Penguin Cold Caps |
|---|---|
| Global Health Status | 64.58 ± 19.8 |
| Functional Scale: Physical | 84.17 ± 16.3 |
| Functional Scale: Role | 62 ± 21.7 |
| Functional Scale: Emotional | 69.79 ± 24.8 |
| Functional Scale: Cognitive | 64.58 ± 22.6 |
| Functional Scale: Social | 70.84 ± 26.3 |
| Symptom Scale: Financial Difficulties | 33.33 ± 39.8 |
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.
| score on a scale | Penguin Cold Caps |
|---|---|
| Functional Scales (BR23): Body Image | 64.58 ± 21.7 |
| Functional Scales (BR23): Future Perspective | 41.67 ± 29.6 |
| Symptom Scale (BIS): Upset by Hair Loss | 4.17 ± 23.5 |
Collected over 11 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Penguin Cold Caps | 0/10 (0%) | 0/10 (0%) | 10/10 (100%) |
| Event | Penguin Cold Caps |
|---|---|
| NauseaGastrointestinal disorders | 9/10 |
| HeadacheNervous system disorders | 2/10 |
| VomitingGastrointestinal disorders | 2/10 |
| Head SoreSkin and subcutaneous tissue disorders | 1/10 |
| SyncopeNervous system disorders | 1/10 |
Population analyzed reduced to 10 for publication due to two patients withdrawing before Cycle 1.
| Age, Continuous(years) | Penguin Cold Caps |
|---|---|
| Median | 49 (44 to 59) |
| Sex: Female, Male(Participants) | Penguin Cold Caps |
|---|---|
| Female | 10 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Penguin Cold Caps |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Penguin Cold Caps |
|---|---|
| United States | 10 |
| Menopausal Status(Participants) | Penguin Cold Caps |
|---|---|
| Pre-Menopausal | 6 |
| Post-Menopausal | 2 |
| Unknown | 2 |
| Chemotherapy Setting(Participants) | Penguin Cold Caps |
|---|---|
| Adjuvant | 4 |
| Neoadjuvant | 6 |
| Hair Thickness(Participants) | Penguin Cold Caps |
|---|---|
| Fine | 3 |
| Medium | 4 |
| Thick | 3 |
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Providence Health & Services