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A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS (PEG-Thermal)

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ClinicalTrials.gov Identifier: NCT02490943
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Evergreen Healthcare
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH

Brief Summary:
Peginterferon-beta-1a (PEG) is an approved treatment for relapsing forms of MS that may cause injection related erythema. This is a randomized controlled cross-over trial of superficial hot and cold modalities to reduce injection site erythema caused by PEG.

Condition or disease Intervention/treatment Phase
MS (Multiple Sclerosis) Erythema Other: Warm Compress Before Injection Other: Cold Compress After Injection Not Applicable

Detailed Description:

The most common adverse event associated with this subcutaneously (SC) injected drug is injection site reaction (ISR) including redness and pain.Theoretically, both heat and cold modalities may improve interferon injection tolerance. Warm compress before injection may increase local blood flow and increase rapid systemic absorption, while cold compress afterward may reduce the erythema, edema and pain that often follow SC injections. A trial comparing heat-before and cold-after therapy is warranted to determine the relative effectiveness of these modalities.

Intervention:

Product: Reusable cold and warm compress.

Patients will receive written instructions for microwave heating and freezer cooling of the compress.

Warm compress: Pre-heating in microwave oven, per instructions. Apply warm compress for 5 minutes prior to injection. The initial compress temperature will be about 43 degrees Celsius (range 40-46 degrees Celsius) and slowly decline during application. Administer drug soon after removal.

Cold compress: Cooling in a freezer as per instructions. Soon after drug injection, apply cold compress for 10 minutes. The initial compress temperature will range 15-18 degrees Celsius.

  • Timers will be utilized to mark 5-minute and 10-minute treatment intervals
  • Participants will be encouraged to maintain constant practices with regards to non-steroidal anti-inflammatory drug use during the study

Study Objectives:

  1. To assess and compare the impact on erythema of two thermal treatments: warm compress prior to PEG injection and cold compress following PEG injection
  2. To assess the natural history of PEG-erythema over time. This will be accomplished with 18 weeks of observation in the control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
Study Start Date : June 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Warm Compress Pre-Injection
Group A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
Other: Warm Compress Before Injection
Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
Other Name: Group A

Active Comparator: Cold Compress Post-Injection
Group B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
Other: Cold Compress After Injection
Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
Other Name: Group B

No Intervention: No Intervention Pre/Post-Injection
Group C, N= 8, will receive no treatment for six injections following screening.



Primary Outcome Measures :
  1. Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks. [ Time Frame: 24 hours, 7 days, 14 days ]
    Participants will record the diameter of patch of skin discoloration in millimeters, measuring at the maximum width.


Secondary Outcome Measures :
  1. Change from baseline in rating of Modified Local Injection Site Reaction Scale [ Time Frame: 24 hours ]
  2. Erythema score on the Visual Assessment Scale. [ Time Frame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days. ]
    This is a 5 point visual assessment scale. Participants will be asked to observe the change in skin color at the site of injection. They will rate the intensity of skin color change (erythema) using the scale below. These assessments will be recorded at the following time points: 24 hours, 7 days, and 14 days

  3. Pain score on the visual analogue scale after 10-minutes. [ Time Frame: 10 min. ]
    (post-injection, 0-10 visual analogue scale (VAS))

  4. Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days [ Time Frame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days. ]
    (post-injection, 0-10 visual analogue scale (VAS))

  5. Level of Comfort Post-Injection Impression of Last 3 Weeks. [ Time Frame: 18 Weeks ]
    This is a single question: "How would you rate your level of comfort with the last three injections?" This is on a 0-10 VAS with 0= "extremely bad" 5="neither good nor bad" and 10= "extremely good." The question will be answered at the end of each phase of the study.



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

Inclusion Criteria:

  • Diagnosis of MS made at least 3 months prior based on McDonald criteria.
  • Age 18 or more
  • Ongoing treatment with PEG for 30 days or more at screening
  • No MS exacerbation for 60 days prior to screening.
  • Score of ≥50 on screening ISR Erythema Index
  • Home access to microwave oven and freezer
  • Written informed consent

Exclusion Criteria:

  • Any contraindication to warm or cold compress:

    • Inability to sense temperature change by patient report
    • Metal implant near injection site (e.g. injection near intra-abdominal baclofen pump)
    • History of allergy or intolerance to local heat or cold application
    • Bleeding disorder
  • Concomitant use of any topical prescription medication at injection site
  • Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures)
  • Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing.
  • Any other serious and/or unstable medical condition

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): NCT02490943


Contacts
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Contact: Caleb J Cabrera 425-899-5370 CJCabrera@evergreenhealthcare.org
Contact: Carey L Gonzales 425-899-5374 CLGonzales@evergreenhealthcare.org

Locations
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United States, Washington
Evergreen Health Recruiting
Kirkland, Washington, United States, 98034
Contact: Caleb Cabrera    425-899-5370    CJCabrera@evergreenhealthcare.org   
Contact: Carey Gonzales    425-899-5374    CLGonzaels@evergreenhealthcare.org   
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Evergreen Healthcare
Investigators
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Principal Investigator: Theodore R Brown, M.D., MPH Evergreen Health Nueroscience Institute

Additional Information:
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Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT02490943    
Other Study ID Numbers: TRB2015
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Brown, Theodore R., M.D., MPH:
peginterferon beta-1a
MS (Multiple Sclerosis)
Injection Site Reaction Erythema
Additional relevant MeSH terms:
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Multiple Sclerosis
Erythema
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Interferon-beta
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs