Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

NCT03289364 | Completed Results

• 1 other identifier: 2017000277
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 stage breast cancer.

Conditions

Breast Cancer

Keywords

Breast Cancer; Alopecia; Hair Loss; Scalp Cooling; Penguin Cold Caps

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days post chemotherapy treatment

Secondary Outcomes (3)

• "Was It Worth It?" Questionnaire Exit Interview

  30 days post chemotherapy treatment

• EORTC QLQ-C30 Exit Interview

  30 days post chemotherapy treatment

• BR23 Exit Interview

  30 days post chemotherapy

Study Arms (1)

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.

Device: Penguin Cold Caps

Interventions

Penguin Cold Caps DEVICE

Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.

Penguin Cold Caps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• Medical Specialties of California: collaborator

Study Sites (1)

Providence Cancer Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Alopecia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David B. Page
• Organization: Earle A. Chiles Research Institute, Providence Cancer Institute

david.page2@providence.org

503-215-6588

Study Officials

• David Page, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: August 24, 2017
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)