Trial Outcomes & Findings for Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma (NCT NCT05961215)

NCT ID: NCT05961215

Last Updated: 2025-10-27

Results Overview

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 camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Screening (Day 0), Day 30
• Results posted on: 2025-10-27

Participant Flow

Participant milestones

Measure	Penguin Cold Cap 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. Penguin Cold Cap: Penguin cold cap: administered 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.
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Penguin Cold Cap 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. Penguin Cold Cap: Penguin cold cap: administered 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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Penguin Cold Cap n=30 Participants 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. Penguin Cold Cap: Penguin cold cap: administered 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Age, Continuous	64.43 years STANDARD_DEVIATION 7.76 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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 camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported

Outcome measures

Measure	Penguin Cold Cap n=30 Participants 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. Penguin Cold Cap: Penguin cold cap: administered 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.
Change in Development of Hair Loss Screening · 0 Alopecia	30 Participants
Change in Development of Hair Loss Screening · 1 Level	0 Participants
Change in Development of Hair Loss Screening · 2 Level	0 Participants
Change in Development of Hair Loss Day 30 · 1 Level	4 Participants
Change in Development of Hair Loss Day 30 · 0 Alopecia	26 Participants
Change in Development of Hair Loss Day 30 · 2 Level	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Penguin Cold Cap n=29 Participants 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. Penguin Cold Cap: Penguin cold cap: administered 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.
Patient Determined Decision of Scalp Cooling Benefit A big effect - 4	2 Participants
Patient Determined Decision of Scalp Cooling Benefit Not at all	8 Participants
Patient Determined Decision of Scalp Cooling Benefit Somewhat had an effect - 3	6 Participants
Patient Determined Decision of Scalp Cooling Benefit A little bit - 2	13 Participants

Adverse Events

Penguin Cold Cap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Vescio, MD

Cedars-Sinai Medical Center

Phone: 3104231825

Email: robert.vescio@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place