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NCT05961215

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

Completed NA Results posted Last updated 27 October 2025
What this trial tests

NA trial testing Penguin Cold Cap in Multiple Myeloma in 31 participants. Completed in 3 February 2025.

Timeline
10 August 2023
Primary endpoint
1 November 2024
3 February 2025

Quick facts

Lead sponsorCedars-Sinai Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment31
Start date10 August 2023
Primary completion1 November 2024
Estimated completion3 February 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Development of Hair Loss Primary · Screening (Day 0), Day 30

Change in development of hair loss will be defined as \< 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated. In CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, alopecia is graded based on the extent of hair loss, with two main grades: Grade 1 (hair loss less than 50%, not obvious from a distance) and Grade 2 (hair loss of 50% or more, readily apparent). Grade 1 alopecia may be manageable with different hairstyles, while Grade 2 typically requires a wig or other ca

Screening
GroupValue95% CI
Penguin Cold Cap30
Penguin Cold Cap0
Penguin Cold Cap0
Day 30
GroupValue95% CI
Penguin Cold Cap4
Penguin Cold Cap26
Penguin Cold Cap0
Patient Determined Decision of Scalp Cooling Benefit Secondary · Day 90

Patient determined decision of scalp cooling benefit will be measured by Scalp Cooling Questionnaire, a homegrown scale ranging from no benefit to substantial benefit, with higher scores representing a better outcome.

GroupValue95% CI
Penguin Cold Cap2
Penguin Cold Cap8
Penguin Cold Cap6
Penguin Cold Cap13

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Cedars-Sinai Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05961215.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing