Breast Cancer
Conditions
Keywords
Breast Cancer, Alopecia, Hair Loss, Scalp Cooling, Penguin Cold Caps
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 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.
Interventions
DEVICEPenguin Cold Caps
Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
Sponsors
Providence Health & Services
Medical Specialties of California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PenguinTM Cold-caps for Prevention or Reduction of CIA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| "Was It Worth It?" Questionnaire Exit Interview | 30 days post chemotherapy treatment | 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. |
| EORTC QLQ-C30 Exit Interview | 30 days post chemotherapy treatment | 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. |
| BR23 Exit Interview | 30 days post chemotherapy | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Page, MD
Providence Health & Services
Participant flow
Pre-assignment details
Slow accrual and exhausted funding led to only 12 patients enrolled instead of the planned 20.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49 years |
| Chemotherapy Setting Adjuvant | 4 Participants |
| Chemotherapy Setting Neoadjuvant | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hair Thickness Fine | 3 Participants |
| Hair Thickness Medium | 4 Participants |
| Hair Thickness Thick | 3 Participants |
| Menopausal Status Post-Menopausal | 2 Participants |
| Menopausal Status Pre-Menopausal | 6 Participants |
| Menopausal Status Unknown | 2 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
None listed