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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a cold cap can prevent hair loss in people with multiple myeloma undergoing strong chemotherapy. Participants will wear a Penguin Cold Cap before and after chemotherapy to determine its effectiveness in reducing hair loss. The trial also examines whether the benefits of retaining hair outweigh any discomfort from the cold cap process. It seeks individuals with multiple myeloma who are about to receive high-dose melphalan chemotherapy and have hair covering at least 75% of their scalp. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance the quality of life for future patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using oxaliplatin or any other investigational agents.

What prior data suggests that scalp cooling with Penguin cold caps is safe for patients with multiple myeloma?

Research has shown that using the Penguin Cold Cap for scalp cooling can help prevent hair loss in patients with multiple myeloma undergoing high-dose chemotherapy. In one study, most patients experienced minimal hair loss, with an average loss of just 2.5% after three months. This indicates that most patients retained nearly all of their hair.

The Penguin Cold Cap is considered a low-risk device, generally safe for use. It is not implanted in the body and does not pose major health risks. Although not FDA-approved, it has been used without any serious side effects reported.

Overall, the treatment appears well-tolerated, with the main issues being the discomfort and inconvenience of wearing the cold cap. For those considering joining a trial, the Penguin Cold Cap has shown promising results in reducing hair loss with few reported problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for multiple myeloma, which focus on tackling the cancer itself, the Penguin Cold Cap offers a new way to manage a side effect of chemotherapy. This treatment involves wearing a specialized cap that cools the scalp before, during, and after chemotherapy sessions. Researchers are excited because this cooling method can help reduce hair loss, a common and distressing side effect of chemotherapy. By focusing on preserving hair, the Penguin Cold Cap aims to improve the quality of life for patients undergoing treatment.

What evidence suggests that scalp cooling is effective for reducing hair loss in multiple myeloma patients?

Research shows that cooling the scalp can help prevent hair loss during chemotherapy. One study found that 65% of patients lost less than 25% of their hair, which is considered a great result. In this trial, patients with multiple myeloma will use the Penguin Cold Cap, which has prevented almost all noticeable hair loss during high-dose chemotherapy. Cooling the scalp slows blood flow to the hair roots, reducing the amount of chemotherapy that reaches them and preventing damage. While scalp cooling is well-known for treating solid tumors, its use in multiple myeloma is gaining popularity due to its promising results. ^{3 4 6 7 8}

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+

Citations

1. penguincoldcaps.com penguincoldcaps.com/cold-cap-info/save-your-hair-during-multiple-myeloma-treatment-how-scalp-cooling-can-make-a-difference/

Save Your Hair During Multiple Myeloma Treatment Penguin Cold Caps: How It Works · The Concept: Scalp cooling slows blood flow to hair follicles, reducing chemo exposure and preventing damage.

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/7080/506229/Scalp-Cooling-to-Prevent-Hair-Loss-in-Multiple

Scalp Cooling to Prevent Hair Loss in Multiple Myeloma ... Scalp cooling has been used to prevent hair loss in patients undergoing chemotherapy for solid tumors, no reports were found for its usage for multiple myeloma.

3. penguincoldcaps.com penguincoldcaps.com/cold-cap-info/the-evidence-that-cold-cap-therapy-works/

The evidence that cold cap therapy works 65% of patients experienced less than 25% hair loss (considered an “excellent” outcome). · 25% reported moderate hair loss (between 25% and 50%).

4. journals.lww.com journals.lww.com/oncology-times/fulltext/2025/04000/cold_cap_therapy_prevents_hair_loss_in_multiple.27.aspx

Cold Cap Therapy Prevents Hair Loss in Multiple Myeloma... Cryotherapy with a scalp cooling device was shown to prevent nearly any detectable hair loss in patients with multiple myeloma undergoing high-dose melphalan ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123136767

Scalp Cooling to Prevent Hair Loss in Multiple Myeloma ... The use of cold caps during chemotherapy exposure time has helped reduce hair loss, presumably by causing vasoconstriction and reducing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124098070

Cryotherapy Prevents Hair Loss in Multiple Myeloma ... The Penguin Scalp cooling device can prevent nearly any detectable hair loss in patients with multiple myeloma undergoing high-dose melphalan chemotherapy.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/15/NCT05961215/Prot_SAP_000.pdf

IIT2023-03-Vescio-ColdCap Scalp Cooling to Prevent Hair ... The Penguin cold cap is not FDA cleared and is a nonsignificant risk (NSR) medical device that is: - NOT intended as an implant and presents a potential for ...

8. astct.org astct.org/Nucleus/Article/scalp-cooling-during-transplantation-for-myeloma-is-hair-loss-avoidable

Scalp Cooling During Transplantation for Myeloma: Is Hair ... Their results were quite impressive: the median degree of patient-reported hair loss after three months was only 2.5%! In fact, 29 out of 30 ...