Wong, S.F., Lindgren, A., Mummaneni, M., Byun, T., Vasko, C., Arenos, R., ... Osann, K. (2010). A prospective crossover pilot study to evaluate the use of a topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor inhibitors. The Journal of Supportive Oncology, 8, 202–208.

DOI Link

Study Purpose

To evaluate the effectiveness of Regenecare® Wound Gel in alleviating the pain and pruritus of EGFR-induced (EGFRI) rash

Intervention Characteristics/Basic Study Process

Enrolled patients received Regenecare® Wound Gel, a viscous hydrogel wound dressing with 2% w/w lidocaine. Facial assessments were conducted weekly for up to six weeks, and patient self-report questionnaires were collected weekly. Patients who developed grade 2 or higher rash applied the gel to the right side of the face three to four times per day for one week. In weeks 2–5, patients applied the gel three to four times per day to both sides of the face. Compliance data were collected at each visit, and patients whose adherence fell below 75% received specialized counseling. If patients were not adherent for two consecutive weeks, they were removed from the study.

Sample Characteristics

  • N = 13
  • MEDIAN AGE = 51.2 years
  • MALES: 54%, FEMALES: 46%
  • KEY DISEASE CHARACTERISTICS: Majority of patients had colorectal cancer and were receiving cetuximab.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Orange County, California

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care 

Study Design

Prospective, crossover

Measurement Instruments/Methods

  • CTCAE version 3.0 for Rash/Desquamation
  • Pain scale (none, mild, moderate, severe)

Results

When the right and left sides of the face were compared, the gel was associated with a significant reduction in pruritus (p = 0.01) but no significant decrease in pain level. The gel also had minimal effect on erythema and swelling as assessed by healthcare providers.

Conclusions

The hydrogel decreased pruritus associated with EGFR-inhibitor associated rash but did not have any influence on pain associated with the rash.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias(sample characteristics)
  • Findings not generalizable

 

Nursing Implications

Nurses should assess patients with EGFR-associated rash for pruritus, including intensity and the level to which it affects patient comfort. Regenecare® Wound Gel may be an effective topical intervention to relieve pruritus and should be considered for a topical treatment. There is no benefit to using the gel for pain relief, and nurses should consider other interventions if patients experience pain associated with the rash.