Clinical trial NCT02490943: A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS
Official title: A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MS (Multiple Sclerosis)
Erythema
Keywords: peginterferon beta-1a
MS (Multiple Sclerosis)
Injection Site Reaction Erythema
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
Collaborators: name: Evergreen Healthcare
First posted: 2015-07-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants were randomized to warm compress (WC) for three injections, followed by cold compress (CC) for three injections, CC followed by WC, each for three injections or no treatment for six injections
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline ISR Erythema Index at 24 hours, 7 days, and 14 days every 6 weeks for 18 weeks.
timeFrame: 24 hours, 7 days, 14 days
Secondary outcomes:
measure: Change from baseline in rating of Modified Local Injection Site Reaction Scale
timeFrame: 24 hours
measure: Erythema score on the Visual Assessment Scale.
timeFrame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
measure: Pain score on the visual analogue scale after 10-minutes.
timeFrame: 10 min.
measure: Pain score on the visual analogue scale Post-Injection 24 hours, 7 days, and 14 days
timeFrame: Change from Baseline in VAS at 24 hours, 7 days, and 14 days.
measure: Level of Comfort Post-Injection Impression of Last 3 Weeks.
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: Evergreen Health
state: Washington
Study officials:
affiliation: Evergreen Health Nueroscience Institute
name: Theodore R Brown, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: