Abstract

Disease- or treatment-related pain is a common and often debilitating symptom among head and neck cancer (HNC) patients. Inadequate pain control is associated with psychological distress, reduced social activities, decreased social support, and increased frequency of treatment interruptions which has been linked to worse outcomes. The purpose of this analysis was to determine the effect of protocol treatment on patient-reported pain in HNC patients undergoing radiation. The nurse-assessed pain intensity numeric rating scale (PI-NRS) scores were reviewed for patients with HNC enrolled in a prospective trial of microsphere oxycodone for extended release analgesia during RT (NCT03317730). Analgesia was prescribed in accordance with the World Health Organization pain ladder with the only restriction being that the extended release opioid analgesic was microsphere oxycodone. A comparison cohort was constructed by matching participants in the protocol cohort 5-to-1 at the individual patient level based on stage, tumor location, gender, and pain at presentation. Patients in the usual care cohort were prescribed analgesia at the discretion of the treating physician. In both cohorts, pain was assessed once weekly during RT and at 1 and 3 months after completion of RT. PI-NRS scores were characterized as mild (0-3), moderate (4-6), or severe (7-10). Between group differences of frequencies were assessed using the χ2 test and means were assessed using the independent samples T-test or non-parametric independent samples testing, where appropriate. The 26 eligible patients enrolled in the clinical trial comprised the protocol cohort and 130 patients were in the usual care cohort. No statistically significant differences were observed with respect to baseline patient and treatment characteristics. The PI-NRS at time of consultation for patients in the protocol cohort was 2.0 (SD ±2.5) and was 2.5 (SD ±3.0) in the usual care cohort (p = 0.74). Patients treated in the protocol cohort rated their pain as moderate or severe in 32.0% of encounters as compared to 46.1% of encounters within the usual care cohort (p = 0.043). Patients treated in the protocol cohort rated their pain as severe in 15.6% of encounters as compared to 17.9% of encounters within the usual care cohort (p = 0.65). In this study, patients with HNC who participated in a supportive care clinical trial of microsphere oxycodone for pain management during radiation were less likely to report moderate-to-severe pain than patients treated with usual care. No differences in the frequency of severe pain was noted. Ongoing research is critically needed to determine the optimal pain management strategy for patients with HNC.

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