Hair Loss Prevention Study for Pancreatic Cancer

Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492800
• Other study ID #: HRI-ScalpCooling-001
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 31, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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