Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Alopecia

Alopecia Areata

Skin Diseases

Hypotrichosis

Hair Diseases

Pathological Conditions, Anatomical

PAXMAN Orbis Scalp Cooler

Control No treatment

Julie Nangia, M.D.

Determine 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.

Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.

One blinded observer assesses the patient outcome

Scalp Cooling to Prevent Chemo-induced Hair Loss

Scalp Cooling for Alopecia Prevention (SCALP)

Patients are aware of whether or not they are using the cooling device and can tell if they have hair loss.

Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.

The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.

A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation

Julie Nangia

Assistant Professor

Any adverse events that are possibly, probably, or definitely related to the Orbis Paxman Hair Loss Prevention System were reported. Any toxicities were determined to be related to the chemotherapy were monitored and only reported if they were unusual. Subjects who were randomized to the scalp cooling and started the first cycle of chemotherapy were evaluable for safety analyses.

No adverse event from non-cooling subjects since they did not use the device so they were not at risk.

Scalp Cooling

PAXMAN Orbis Scalp Cooler: Treatment with Orbis scalp cooling cap

Scalp Cooling

Control

Control No Treatment: No treatment to prevent hair loss

Non-cooling

Control

Control No treatment: No treatment to prevent hair loss

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Tao Wang

Randomized patients who underwent at least one cycle of chemotherapy were evaluable for efficacy. 27 patients in the cooling group and 25 patients in the non-cooling group did not start chemotherapy or discontinued during the 1st cycle were excluded from the efficacy analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center
Scalp Cooling to Prevent Chemo-induced Hair Loss	NCT01986140	Breast Cancer Alopecia	PAXMAN Orbis Sc... Control No trea...	18 Years -	Baylor Breast Care Center

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