Breast CancerNCT03289364
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
A study testing Penguin Cold Caps in people with Breast Cancer, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Penguin Cold Caps
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer
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.
Read the 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 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.
- Conditions
- Breast Cancer
- Being tested
- Penguin Cold Caps
- Keywords
- Breast Cancer, Alopecia, Hair Loss, Scalp Cooling, Penguin Cold Caps
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penguin Cold CapsDevice
Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
| Study group | Role | What they receive |
|---|---|---|
| Penguin Cold Caps | Experimental | Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. Receives: Device: Penguin Cold Caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post chemotherapy treatment
Secondary outcomes (3)
"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.
Measured: 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.
Measured: 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.
Measured: 30 days post chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start24 Aug 2017
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Specialties of California
- Responsible party
- Sponsor
- Investigators
- David Page, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289364
- Sponsor's protocol ID
- 2017000277
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2017
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer
- ClinicalTrials.gov ID
- NCT03289364
- Acronym / sponsor ID
- 2017000277
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Alopecia, Hair Loss, Scalp Cooling, Penguin Cold Caps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Medical Specialties of California
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 20 Sep 2017 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Penguin Cold Caps | Experimental | Device: Penguin Cold CapsPenguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penguin Cold CapsPatients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration. | Device | Penguin Cold Caps |
Primary outcome
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA
Time frame: 30 days post chemotherapy treatment
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.
3 secondary outcomes
"Was It Worth It?" Questionnaire Exit Interview
Time frame: 30 days post chemotherapy treatment
EORTC QLQ-C30 Exit Interview
Time frame: 30 days post chemotherapy treatment
BR23 Exit Interview
Time frame: 30 days post chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Page, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penguin Cold Caps in people with Breast Cancer, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA (time frame: 30 days post chemotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.