Scalp Cooling for Multiple Myeloma

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must be taking: Chemotherapy

Must not be taking: Oxaliplatin, Investigational agents

Disqualifiers: Reynaud's, Cold sensitivity, Skin conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Robert Vescio, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who are about to receive high-dose chemotherapy and a stem cell transplant. They must have good performance status, sufficient hair coverage, and be able to follow the study's procedures. People with cold-related diseases, certain skin conditions, spinal or neck injuries, or those using specific medications cannot participate.

Inclusion Criteria

My hair covers most of my head.

I am 18 years old or older.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria

I cannot take melphalan due to health reasons.

I do not have conditions related to cold sensitivity like Reynaud's disease.

Less than 75% of my scalp is covered with hair.

Treatment Details

Interventions

• Penguin Cold Cap

Trial Overview The study tests if Penguin Cold Caps can prevent hair loss in patients undergoing treatment for multiple myeloma. It involves wearing these special caps during chemotherapy sessions at Cedars-Sinai Medical Center to see if they reduce hair loss without causing too much discomfort.

Participant Groups

Group I: Penguin Cold Cap Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Penguin Cold Caps

Collaborator

Trials

1

Recruited

30+