NCT05961215 · OUTCOME
Change in Development of Hair Loss
Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma · Source last updated 2025-10-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Screening (Day 0), Day 30
What was measured
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
Groups in this outcome
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Penguin Cold Cap | 30 |
|---|
Reported measurements
Screening
0 Alopecia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
1 Level
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
2 Level
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 30
1 Level
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
0 Alopecia
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
2 Level
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Penguin Cold Cap | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- title
- 0 Alopecia
- title
- 1 Level
- title
- 2 Level
- title
- Screening
- categories
- title
- 1 Level
- title
- 0 Alopecia
- title
- 2 Level
- title
- Day 30
- description
- 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
- groups
- description
- 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.
- id
- OG000
- title
- Penguin Cold Cap
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Screening (Day 0), Day 30
- title
- Change in Development of Hair Loss
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle