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Hair Loss Prevention Study for Pancreatic Cancer

Primary Purpose

Alopecia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paxman Scalp Cooling Device
Sponsored by
HonorHealth Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HonorHealth Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Paxman Scalp Cooling Device

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Comfort
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
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

Full Information

First Posted
July 27, 2020
Last Updated
February 22, 2022
Sponsor
HonorHealth Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04492800
Brief Title
Hair Loss Prevention Study for Pancreatic Cancer
Official Title
A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paxman Scalp Cooling Device
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Paxman Scalp Cooling Device
Intervention Description
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 Measure Information:
Title
Hair Preservation
Description
Patients will experience hair preservation defined as alopecia Grade 0 or 1 versus Grade 2 as defined by the CTCAE Version 5.0
Time Frame
28 to 84 days
Secondary Outcome Measure Information:
Title
Patient Comfort
Description
Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)
Time Frame
1 to 84 days
Title
Chemotherapy-Induced Alopecia Distress
Description
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
Time Frame
1 to 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Mirabella, PhD, RN, CHPN
Organizational Affiliation
HonorHealth Research Institute - Bisgrove
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States

12. IPD Sharing Statement

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Hair Loss Prevention Study for Pancreatic Cancer

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