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Completed

NCT Number: NCT04492800

Hair Loss Prevention Study for Pancreatic Cancer

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

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Key information

Conditions

Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • 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

Treatment and study plan

Paxman Scalp Cooling Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Comfort

    Time frame: 1 to 84 days

    Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)

  2. Chemotherapy-Induced Alopecia Distress

    Time frame: 1 to 84 days

    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

Sponsors and collaborators

Lead sponsor

HonorHealth Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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