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Scalp Cooling for Multiple Myeloma

N/A
Recruiting
Led By Robert Vescio, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hair covering ≥75% of scalp on physical exam at screening visit
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of study treatment (day -2) until day 30.
Awards & highlights

Study Summary

This trial will study how scalp cooling can reduce hair loss in 30 people with multiple myeloma undergoing chemo. It'll also look at how the scalp cooling procedure affects comfort & convenience.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from scalp cooling may include headaches, neck and shoulder discomfort, chills, and a risk of the cap not fully preventing hair loss. The procedure might also feel uncomfortable due to the cold temperature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hair covers most of my head.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I am scheduled for high-dose chemotherapy followed by a stem cell transplant.
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I have been diagnosed with multiple myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of study treatment (day -2) until day 30.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study treatment (day -2) until day 30. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in development of hair loss
Secondary outcome measures
Patient determined decision of scalp cooling benefit

Trial Design

1Treatment groups
Experimental Treatment
Group I: Penguin Cold CapExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,833 Total Patients Enrolled
2 Trials studying Multiple Myeloma
31 Patients Enrolled for Multiple Myeloma
Penguin Cold CapsUNKNOWN
Robert Vescio, MDPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Penguin Cold Cap Clinical Trial Eligibility Overview. Trial Name: NCT05961215 — N/A
Multiple Myeloma Research Study Groups: Penguin Cold Cap
Multiple Myeloma Clinical Trial 2023: Penguin Cold Cap Highlights & Side Effects. Trial Name: NCT05961215 — N/A
Penguin Cold Cap 2023 Treatment Timeline for Medical Study. Trial Name: NCT05961215 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this research project at the moment?

"The trial posted on July 1st, 2023 is not currently seeking participants. However, there are 820 other clinical studies recruiting patients at this time according to the data hosted on Clinicaltrials.gov."

Answered by AI
~19 spots leftby Jun 2025