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

NCT ID: NCT02490943

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-04-30

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.

Conditions

MS (Multiple Sclerosis); Erythema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Warm Compress Before Injection

Intervention Type: OTHER

Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.

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.

Group Type: ACTIVE_COMPARATOR

Cold Compress After Injection

Intervention Type: OTHER

Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

No Intervention Pre/Post-Injection

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Warm Compress Before Injection

Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.

Intervention Type: OTHER

Cold Compress After Injection

Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.

Intervention Type: OTHER

Other Intervention Names

Group A; Group B

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evergreen Healthcare

OTHER

Sponsor Role: collaborator

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

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore R Brown, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Evergreen Health Nueroscience Institute

Locations

Evergreen Health

Kirkland, Washington, United States

Countries

United States

Other Identifiers

TRB2015

Identifier Type: -

Identifier Source: org_study_id