Efficacy of Prophylactic High-Dose Gabapentin and Venlafaxine on Reducing Oral Mucositis Pain Among Patients Treated With Chemoradiation for Head and Neck Cancer: A Single-Institution, Phase 2, Randomized Clinical Trial.

PURPOSE: Given the paucity of level 1 evidence, the optimal regimen to control oral mucositis pain remains unclear. Although national guidelines allow consideration of prophylactic gabapentin, prior trials showed improved pain control with venlafaxine among patients with diabetic neuropathy. We sought to investigate the role of prophylactic high-dose gabapentin with venlafaxine to reduce oral mucositis pain among patients with head and neck cancer. METHODS AND MATERIALS: We performed a single-institution, phase 2 randomized trial on nonmetastatic squamous cell carcinoma of the head and neck treated with chemoradiation. Patients were randomized to either prophylactic gabapentin (3600 mg daily) with or without venlafaxine (150 mg daily). Primary endpoint was differences in pain levels at the end of chemoradiation. Secondary endpoint was toxicity profiles, quality of life changes, opioid use, and feeding tube placement. Differences between the 2 arms at multiple time points were evaluated using a generalized linear mixed regression model with Sidak correction. RESULTS: Between May 2018 and March 2021, a total of 62 patients were enrolled and evaluable for analysis (n = 32 for the gabapentin alone arm, n = 30 for the gabapentin + venlafaxine arm). Over 90% of patients tolerated gabapentin well. Head and neck pain level showed a mean value of 45 (standard deviation, 23) and 43 (standard deviation, 21) for the gabapentin alone and the gabapentin + venlafaxine arms, respectively (P = .65). No statistically significant differences were observed in adverse events, opioid use, feeding tube placement, or quality of life. CONCLUSIONS: The addition of venlafaxine to prophylactic gabapentin did not result in improvements in pain control and quality of life among patients with head and neck cancer.

A nursing workforce program to advance knowledge and skills for nurses implementing cancer clinical research.

Clinical nursing research is an emerging subspecialty that enhances nursing expertise. In an effort to provide a basic educational curriculum on cancer research and clinical trials, a major academic cancer center launched a novel program titled Clinical Research Nursing Grand Rounds that allowed nurses to receive continuing education units. The purpose of the current article is to describe the development and content of the education model, challenges encountered, and implications for oncology nursing education, practice, and research.