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

Duration: 2 days

31 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Robert Vescio, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

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

I can take care of myself but might not be able to do heavy physical work.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Penguin cold cap treatment for 6 hours on Days -2 and -1, in conjunction with high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant

2 days

In-patient during stem cell transplantation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of hair loss and patient satisfaction with scalp cooling

90 days

Follow-up assessments at Day 0 and Day 90

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+