Hair Loss Prevention Study for Pancreatic Cancer

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

Detailed Description
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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.

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

Conditions
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Alopecia

Intervention / Treatment
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* Device: Paxman Scalp Cooling Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Paxman Scalp Cooling Device<br>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). | Device: Paxman Scalp Cooling Device<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Preservation | Patients will experience hair preservation defined as alopecia Grade 0 or 1 versus Grade 2 as defined by the CTCAE Version 5.0 | 28 to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort | Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable) | 1 to 84 days | 
| Chemotherapy-Induced Alopecia Distress | Identify chemotherapy-induced alopecia distress by utilizing the chemotherapy-induced alopecia distress scale (CADS) with scores ranging from 17-68 with a higher score indicating distress | 1 to 84 days |