Clinical trial NCT03289364: Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Alopecia
Hair Loss
Scalp Cooling
Penguin Cold Caps
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Medical Specialties of California
First posted: 2017-09-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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 (Table 5) 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.

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.

Primary outcomes:
measure: Deans Alopecia Scale
timeFrame: 30 days post chemotherapy treatment
Secondary outcomes:
measure: Was it Worth it Questionnaire
timeFrame: 30 days post chemotherapy treatment
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
timeFrame: 30 days post chemotherapy treatment
measure: Body Image Scale Questionnaire
timeFrame: 30 days post chemotherapy treatment
measure: Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: 30 days post chemotherapy treatment
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Cancer Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: David Page, MD
role: PRINCIPAL_INVESTIGATOR
References: