Objective: To evaluate possible determinants of OMP, and the effect of those determinants, and misoprostol prophylaxis, on need for selected supportive services and quality of life (QoL) of patients.
Methods: In this randomized, double-blind trial, 39 patients were assigned to receive misoprostol (n = 18) or placebo (n = 21) from first day of chemotherapy until one day prior to ASCT. Pain and QoL data were collected using self-report questionnaires. Mucosal injury (erythema, ulceration) was measured by calibrated examiners using the Oral Mucositis Index (OMI). Statistical analyses examined effects of age, gender, mucosal injury and study drug on maximum OMP, need for supportive services and QoL.
Results: Age, gender and misoprostol prophylaxis were not significantly associated with maximum OMP. Maximum OMP correlated significantly with OMI (p < 0.001). Erythema and ulceration accounted for 64% of the variance in maximum OMP ratings. Daily opioid requirement increased significantly with increasing age (p = 0.04). Need for total parenteral nutrition (TPN) was greater in women than men (11.6 ± 6.8 days vs. 4.6 ± 6.6 days respectively, p = 0.006). QoL exhibited an expected decline over the duration of study (p < 0.001), independent of study drug assignment.
Conclusions: OMI can be a useful predictor of severity of OMP in patients receiving myeloablative chemotherapy. Elderly patients and women are more likely to require greater analgesic and TPN support, respectively. Further study of the mechanistic interactions among pain, mucosal injury and patient psychosocial status is warranted.
Supported by NIH # 5/T32/ DE07136-20 and Searle Pharmaceuticals.