Scalp Cooling to Prevent Chemo-induced Hair Loss

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Scalp Cooling for Alopecia Prevention (SCALP)

Conditions
-----------------
Breast Cancer, Alopecia

Intervention / Treatment
-----------------
* Device: PAXMAN Orbis Scalp Cooler
* Other: Control No treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of breast cancer stage 1-2 Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen, Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses Concurrent traztuzumab at standard doses is allowed Concurrent pertuzumab at standard doses is allowed Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated. Subjects must have TSH collected within 1 year prior to treatment and found within normal range. If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits. CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits. Exclusion Criteria: Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale) Subjects with cold agglutinin disease or cold urticaria Subjects who are scheduled for bone marrow ablation chemotherapy Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC) Male gender Age >= 70 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAXMAN Orbis Scalp Cooler<br>Scalp Cooling | Device: PAXMAN Orbis Scalp Cooler<br>* Treatment with Orbis scalp cooling cap<br>|
| Other: Control No treatment<br>Control | Other: Control No treatment<br>* No treatment to prevent hair loss<br>* Other names: No intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Preservation | 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. | 4 to 8 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Recurrence and Overall Survival | 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 | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Alopecia, Scalp, Cooling