WASHINGTON, DC—Using fentanyl sublingual spray for breakthrough pain in patients with cancer leads to a high degree of patient satisfaction across a heterogeneous cohort, results of a randomized, double-blind, placebo-controlled clinical trial presented at the Oncology Nursing Society (ONS) 38th Annual Congress have shown.
The multicenter study examined patient satisfaction of fentanyl sublingual spray for breakthrough pain in patients with different types and stages of cancer, explained Michelle Rhiner, RNBC, MSN, GNP-BC, ACHPN, CCM, of Loma Linda University Medical Center, Loma Linda, CA.
“Breakthrough cancer pain is often inadequately treated with short-acting opioids and negatively impacts quality of life,” she noted. “Oncology nurses are ethically and morally mandated to assess the multifaceted components of pain and advocate for improved comfort and satisfaction while maintaining patient safety.”
The study enrolled 130 adults ≥18 years who were receiving around-the-clock opioids for baseline pain with 1 to 4 episodes per day of breakthrough cancer pain in a 26-day open-label titration phase. The 96 patients who successfully titrated to a stable, effective dose (100-1600 mcg) of fentanyl sublingual spray were enrolled in the 26-day double-blind phase; each received 7 active doses of fentanyl sublingual spray and 3 placebo doses. Of these, 95 patients completed the double-blind treatment period, and 90 of these patients (94.7%) chose to continue to an open-label extension.
The investigators assessed patient satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM); higher scores on the 0-100 scale indicated greater satisfaction. “Patients were instructed to base responses on usual medication at baseline (before titration) and study medication posttitration (before randomization),” Rhiner noted. Adverse events were recorded.
In the titration phase, mean patient age (SD) was 55.6 (12.2) years. The most common cancers were reproductive (30.0%), breast (17.7%), lung (17.7%), skin (12.3%), and head/neck (12.3%). Mean (SD) duration of cancer was 7.5 (9.4) years; 59.2% of cancers were stages 2 (10.8%), 3 (17.7%), and 4 (30.8%).
They found that TSQM scores improved after titration: mean (SD) change from baseline to posttitration was 22.3 (25.0) for Effectiveness, 7.7 (34.1) for Side Effects, 6.8 (23.1) for Convenience, and 12.9 (29.7) for Global Satisfaction (all P<0.05), Rhiner repoted.
Posttitration, 88.5% of patients were satisfied with treatment compared with 40.8% at baseline. Adverse events were reported for 60.0% of patients during titration, with nausea (7.7%) being the most common. The severity of adverse events was reported to be mild or moderate in most (87.2%) patients.
“Fentanyl sublingual spray was associated with improvements in patient satisfaction over all domains compared with previous BTCP medication. Global satisfaction and effectiveness domains improved during titration of fentanyl sublingual spray across all stages and types of cancer,” the authors concluded.