AlopeciaNCT04492800

Hair Loss Prevention Study for Pancreatic Cancer

A study testing Paxman Scalp Cooling Device in people with Alopecia, run by HonorHealth Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alopecia
What is being tested?: Paxman Scalp Cooling Device
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 13 Dec 2019to 31 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to provide written informed consent/assent for the trial
>18 years of age on day of signing informed consent
Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin

Who cannot join

Grade 1 alopecia
Existing history of scalp metastases or the presence of scalp metastases is suspected
No history of previous cancers within the past 5 years
Central Nervous System (CNS) malignancies (either primary or metastatic)
Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy
Imminent bone marrow ablation chemotherapy

Show all 13Show fewer

Imminent skull radiation
Previously received or scheduled to undergo skull irradiation
Severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent
Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma
Small cell carcinoma of the lung
Solid tumors that have a high likelihood for metastasis in transit
Squamous cell carcinoma of the lung

Trial locations and contacts

1 site in 1 country.

United States1 site

HonorHealth Research Institute
Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling

Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

Read the detailed description

Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.

Conditions: Alopecia
Being tested: Paxman Scalp Cooling Device
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paxman Scalp Cooling DeviceDevice
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).

Study groups in NCT04492800
Study group	Role	What they receive
Paxman Scalp Cooling Device	Other	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). Receives: Device: Paxman Scalp Cooling Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Hair Preservation
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.
Measured: 28 to 84 days

Secondary outcomes (2)

Patient Comfort
Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)
Measured: 1 to 84 days
Chemotherapy-Induced Alopecia Distress
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
Measured: 1 to 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201931 Dec 2021

First posted30 Jul 2020
Study start13 Dec 2019
Primary completion20 Apr 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AlopeciaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04492800
Sponsor's protocol ID: HRI-ScalpCooling-001
Status last verified: Apr 2026
First submitted: 27 Jul 2020
Last updated: 26 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
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Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

All Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
ClinicalTrials.gov ID: NCT04492800
Acronym / sponsor ID: HRI-ScalpCooling-001
Conditions: Alopecia
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: HonorHealth Research InstituteUniversity, hospital or other
Study start: 13 Dec 2019 (actual)
Primary completion: 20 Apr 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 30 Jul 2020 (actual)
Results: Posted 26 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paxman Scalp Cooling Device	Other	Device: Paxman Scalp Cooling DevicePatients 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Willing and able to provide written informed consent/assent for the trial
>18 years of age on day of signing informed consent
Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin

Key exclusion criteria (13 listed)

Grade 1 alopecia
Existing history of scalp metastases or the presence of scalp metastases is suspected
No history of previous cancers within the past 5 years
Central Nervous System (CNS) malignancies (either primary or metastatic)
Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paxman Scalp Cooling DeviceCooling 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).	Device	Paxman Scalp Cooling Device

Primary outcome

Hair Preservation
Time frame: 28 to 84 days
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.

2 secondary outcomes

Patient Comfort
Time frame: 1 to 84 days
Chemotherapy-Induced Alopecia Distress
Time frame: 1 to 84 days

Results and safety

Results posted to the registry on 26 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paxman Scalp Cooling Device	9	9

Primary outcome: Hair Preservation

Time frame: 28 to 84 days. Count of participants. Unit: Participants

Measure	Paxman Scalp Cooling Device n = 5
Grade 1 alopecia	2
Grade 2 alopecia	3

Population analysed: Only five (n=5) patients were analyzed due four (n=4) patients' early discontinuation of treatment

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paxman Scalp Cooling Device	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Alopecia

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
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Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Mirabella, PhD, RN, CHPN principal investigator

HonorHealth Research Institute - Bisgrove

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Paxman Scalp Cooling Device in people with Alopecia, run by HonorHealth Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair Preservation (time frame: 28 to 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04492800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.