WASHINGTON, DC—Topical 1% sildenafil cream is well-tolerated, feasible to administer, and may help mitigate hand-foot syndrome, results of a randomized, double-blind, placebo-controlled pilot study presented at the Oncology Nursing Society (ONS) 38th Annual Congress has shown.
Currently, no treatment is available for hand-foot syndrome (palmar-plantar erythrodysesthesia), a common adverse event of many anticancer agents, other than dose reduction or treatment discontinuation. Recent anecdotal evidence suggested that topical sildenafil may improve hand-foot syndrome-related symptoms, reported Wanda Honeycutt, RN, BSN, CCRP, of Duke Cancer Institute, Duke University, in Durham, NC.
The pilot study enrolled 10 patients, who were randomly assigned to apply active 1% sildenafil cream to either the right or left hand and/or foot and placebo cream to the opposite hand and/or foot. Each patient was supplied with nonlatex waterproof gloves to minimize contamination and used a metered dispenser to apply 0.5 mL cream to each affected hand/foot twice daily using Acu-Cap or Topi-Click metered dispensers.
“Use of emollients was encouraged as part of standard care,” Honeycutt noted. “Oncology nursing tools, such as comprehensive diary cards, were developed to record the study cream application, pain, and anticancer treatment.” Patients were given detailed instructions on how to apply the cream and complete the diary card. Clinical assessments were evaluated using NCI CTCAE (v.4.0) grading; patients reported pain at rest and during weight-bearing.
Of the 9 patients evaluable for safety and efficacy, no improvement was observed in hand-foot syndrome CTCAE grading, the primary end point. A trend was noted, however, “for relative improvement for pain and skin changes,” and no treatment-related adverse events were reported. “Subject compliance was high throughout study participation, indicated by robust diary card completion,” Honeycutt stated.
“In this study, oncology nursing was instrumental in developing methods used to educate and measure patient compliance, [and] assess symptom improvement and treatment effect on patient activities of daily living,” she concluded. “Oncology nursing instruments are critical to successfully characterizing patient enthusiasm and compliance for investigational therapies.”