Trial Outcomes & Findings for Hair Loss Prevention Study for Pancreatic Cancer (NCT NCT04492800)
NCT ID: NCT04492800
Last Updated: 2026-05-26
Results Overview
Hair preservation was graded and defined based on severity of hair loss (alopecia) Grade 0 or 1 (lower grade) versus Grade 2 (higher grade) as defined by the CTCAE Version 5.0. Grade 0 to 1 is defined as Hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; Grade 2 or higher is Hair loss of \>=50% normal for that individual that is readily apparent to others.
COMPLETED
NA
9 participants
28 to 84 days
2026-05-26
Participant Flow
Participant milestones
| Measure |
Paxman Scalp Cooling Device
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hair Loss Prevention Study for Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Paxman Scalp Cooling Device
n=9 Participants
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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|---|---|
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Age, Continuous
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63.3 years
STANDARD_DEVIATION 9.4 • n=20 Participants
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Sex: Female, Male
Female
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8 Participants
n=20 Participants
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Sex: Female, Male
Male
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1 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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Race/Ethnicity, Customized
Caucasian
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9 Participants
n=20 Participants
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Race/Ethnicity, Customized
African American
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0 Participants
n=20 Participants
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Race/Ethnicity, Customized
Native American
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0 Participants
n=20 Participants
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Race/Ethnicity, Customized
Asian/Pacific Islander
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0 Participants
n=20 Participants
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Race/Ethnicity, Customized
Other
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0 Participants
n=20 Participants
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Region of Enrollment
United States
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9 Participants
n=20 Participants
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Chemotherapy-Induced Alopecia Distress Scale (CADS)
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17 median score on a scale
STANDARD_DEVIATION 2.0 • n=20 Participants
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PRIMARY outcome
Timeframe: 28 to 84 daysPopulation: Only five (n=5) patients were analyzed due four (n=4) patients' early discontinuation of treatment
Hair preservation was graded and defined based on severity of hair loss (alopecia) Grade 0 or 1 (lower grade) versus Grade 2 (higher grade) as defined by the CTCAE Version 5.0. Grade 0 to 1 is defined as Hair loss of \<50% of normal for that individual that is not obvious from a distance but only on close inspection; Grade 2 or higher is Hair loss of \>=50% normal for that individual that is readily apparent to others.
Outcome measures
| Measure |
Paxman Scalp Cooling Device
n=5 Participants
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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|---|---|
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Hair Preservation
Grade 1 alopecia
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2 Participants
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Hair Preservation
Grade 2 alopecia
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3 Participants
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SECONDARY outcome
Timeframe: 1 to 84 daysPopulation: Only five (n=5) patients were analyzed due four (n=4) patients' early discontinuation of treatment
Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)
Outcome measures
| Measure |
Paxman Scalp Cooling Device
n=5 Participants
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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|---|---|
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Patient Comfort
very comfortable
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5 Participants
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Patient Comfort
reasonably comfortable
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0 Participants
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Patient Comfort
comfortable
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0 Participants
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Patient Comfort
uncomfortable
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0 Participants
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Patient Comfort
very uncomfortable
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0 Participants
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SECONDARY outcome
Timeframe: 1 to 84 daysPopulation: Only seven (n=7) patients were analyzed due two (n=2) patients' inability to tolerate cold from device
Identify chemotherapy-induced alopecia distress by utilizing the chemotherapy-induced alopecia distress scale (CADS) with score totals ranging from 17-68, with a higher score indicating distress
Outcome measures
| Measure |
Paxman Scalp Cooling Device
n=7 Participants
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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|---|---|
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Chemotherapy-Induced Alopecia Distress
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23 score on a scale
Standard Deviation 8.08
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Adverse Events
Paxman Scalp Cooling Device
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paxman Scalp Cooling Device
n=9 participants at risk
Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
Paxman Scalp Cooling Device: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
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Skin and subcutaneous tissue disorders
Alopecia
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55.6%
5/9 • Adverse events were collected during and shortly after treatment with scalp cooling device, up to 30 hours of total device usage over an 84-day period.
Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Nervous system disorders
Headache
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33.3%
3/9 • Adverse events were collected during and shortly after treatment with scalp cooling device, up to 30 hours of total device usage over an 84-day period.
Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Gastrointestinal disorders
Nausea
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22.2%
2/9 • Adverse events were collected during and shortly after treatment with scalp cooling device, up to 30 hours of total device usage over an 84-day period.
Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Additional Information
Amy Mirabella PhD, RN, CHPN
HonorHealth Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place