Hair Loss Prevention Study for Pancreatic Cancer

Not Applicable

Completed

• Conditions: Alopecia
• Interventions: Device: Paxman Scalp Cooling Device

• Registration Number: NCT04492800
• Lead Sponsor: HonorHealth Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Primary Completion: 2021-04-20
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paxman Scalp Cooling Device	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).

Primary Outcome Measures

Name	Time	Method
Hair Preservation	28 to 84 days	Patients will experience hair preservation defined as alopecia Grade 0 or 1 versus Grade 2 as defined by the CTCAE Version 5.0

Secondary Outcome Measures

Name	Time	Method
Patient Comfort	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)
Chemotherapy-Induced Alopecia Distress	1 to 84 days	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

Trial Locations

Locations (1)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States