Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Breast Neoplasms

Respiratory Tract Infections

Alopecia

Alopecia Areata

Breast Diseases

Skin Diseases

Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.

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

David Page, MD

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 (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.

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.

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

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

Number of patients who score from 0-2 on Deans Alopecia Scale

Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.

Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30

These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire

The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale

Medical Specialties of California

Providence Health & Services

Hypotrichosis

Hair Diseases

Pathological Conditions, Anatomical

Scalp cooling is a physical method to reduce chemotherapy-induced alopecia

Scalp cooling

Winnie Yeo, MD, FRCP

The Orbis Paxman Hair Loss Prevention System is a new equipment introduced to Hong Kong in 2017. Although this device has been widely used in the United States, Europe and Australia, acceptability, efficacy and safety data in Chinese have not yet been available. The objective of this prospective study is to collect clinical data in Chinese patients using the Orbis Paxman Hair Loss Prevention System to prevent chemotherapy-induced alopecia.

This project seeks to demonstrate that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

Scalp Cooling Study for the Prevention of Chemotherapy-induced Alopecia in Chinese Breast Cancer Patients

It will be assessed by study tool ALOPECIA ASSESSMENT BY PATIENT AND WIG USE FORM

It will be assessed by study tool EORTC QLQ-30

It will be assessed by study tool EORTC QLQ - BR23

It will be assessed by COMFORT SCALE FORM.

Chinese University of Hong Kong

Professor, Department of Clinical Oncology

Patients have scalp cooling during the chemotherapy period

Patients do not have scalp cooling during the chemotherapy period

The experimental arm will have scalp cooling that starts 30 minutes before the chemotherapy, continues throughout the infusion of the chemotherapy, and lasts for 20-90 minutes more depending on the type of regimen.

Scalp cooling Paxman Orbis II system

The control arm will not have scalp cooling before, during and after chemotherapy.

Standard treatment

Ka Yu Tse

In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.

Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.

Scalp Cooling in Gynecologic Cancer Patients

The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial

Will be assessed by Dean's scale Grade 0 - 4 (from 0% to \>75% hair loss)

Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.

Anxiety and depression scales will be assessed by GAD7 PHQ9. A higher score means the more frequent an event is.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients	NCT03289364	Breast Cancer	Penguin Cold Ca...	18 Years -	Providence Health & Services
Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients	NCT04630080	Breast Cancer	Scalp cooling	18 Years - 70 Years	Chinese University of Hong Kong
Scalp Cooling in Gynecologic Cancer Patients	NCT04168242	Gynecologic Can... Chemotherapy-In...	Scalp cooling P... Standard treatm...	18 Years -	The University of Hong Kong
Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients	NCT04630080	Breast Cancer	Scalp cooling	18 Years - 70 Years	Chinese University of Hong Kong

Spots Global Cancer Trial Database for scalp cooling