Hair Loss Prevention Study for Pancreatic Cancer

NCT04492800 | Completed FDA Device

• 1 other identifier: HRI-ScalpCooling-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Comfort

  1 to 84 days

• Chemotherapy-Induced Alopecia Distress

  1 to 84 days

Study Arms (1)

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).

Device: Paxman Scalp Cooling Device

Interventions

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).

Paxman Scalp Cooling Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Mirabella, PhD, RN, CHPN

  HonorHealth Research Institute - Bisgrove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: December 13, 2019
• Primary Completion: April 20, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)