Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hair Loss Prevention Study for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492800
Recruitment Status : Active, not recruiting
First Posted : July 30, 2020
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alopecia Device: Paxman Scalp Cooling Device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 13, 2019
Actual Primary Completion Date : April 20, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Hair Preservation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492800


Locations
Layout table for location information
United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
HonorHealth Research Institute
Layout table for additonal information
Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT04492800    
Other Study ID Numbers: HRI-ScalpCooling-001
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021

Layout table for additional information
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:
Layout table for MeSH terms
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical