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Hair Loss Prevention Study for Pancreatic Cancer

Sponsor
HonorHealth Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04492800
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
24.6
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Paxman Scalp Cooling Device
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
Actual Study Start Date :
Dec 13, 2019
Actual Primary Completion Date :
Apr 20, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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).

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 HonorHealth Research Institute Scottsdale Arizona United States 85258

Sponsors and Collaborators

  • HonorHealth Research Institute

Investigators

  • Principal Investigator: Amy Mirabella, PhD, RN, CHPN, HonorHealth Research Institute - Bisgrove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HonorHealth Research Institute
ClinicalTrials.gov Identifier:
NCT04492800
Other Study ID Numbers:
  • HRI-ScalpCooling-001
First Posted:
Jul 30, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Alopecia

Study Results

No Results Posted as of Feb 24, 2022