Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

Cedars-Sinai Medical Center

Status: Completed

Conditions: Multiple Myeloma

Treatments: Device: Penguin Cold Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT05961215

IIT2023-03-Vescio-ColdCap

Details and patient eligibility

About

This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• ECOG performance status ≤2
• Confirmed multiple myeloma diagnosis
• Hair covering ≥75% of scalp on physical exam at screening visit
• Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

• Prior or current use of any scalp cooling treatment
• Hair covering < 75% of the scalp on physical exam at screening visit.
• Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
• Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator
• Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Current use of oxaliplatin
• Current use of any other investigational agents
• Contraindication to melphalan

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Penguin Cold Cap

Experimental group

Description:

Patients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.

Treatment:

Device: Penguin Cold Cap