Scalp Cooling to Prevent Chemo-induced Hair Loss (SCALP)

Julie Nangia

Status: Unknown

Conditions: Breast Cancer; Alopecia

Treatments: Other: Control No treatment; Device: PAXMAN Orbis Scalp Cooler

Study type: Interventional

Funder types: Other

Identifiers

NCT01986140

H: 33692 SCALP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

PAXMAN Orbis Scalp Cooler

Experimental group

Description:

Scalp Cooling

Treatment:

Device: PAXMAN Orbis Scalp Cooler

Control No treatment

Other group

Description:

Control

Treatment:

Other: Control No treatment