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

Brown, Theodore R., M.D., MPH

Status: Completed

Conditions: Erythema; MS (Multiple Sclerosis)

Treatments: Other: Cold Compress After Injection; Other: Warm Compress Before Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02490943

TRB2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 3 patient groups

Warm Compress Pre-Injection

Active Comparator group

Description:

Group A, N = 10, will receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.

Treatment:

Other: Warm Compress Before Injection

Cold Compress Post-Injection

Active Comparator group

Description:

Group B, N= 10, will receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

Treatment:

Other: Cold Compress After Injection

No Intervention Pre/Post-Injection

No Intervention group

Description:

Group C, N= 8, will receive no treatment for six injections following screening.