Abstract
BackgroundOral mucositis (OM) is an unpleasant adverse event in patients receiving chemotherapy. A prospective feasibility study showed that elemental diet (ED), an oral supplement that does not require digestion, may prevent OM. Based on this, we established a central review system for oral cavity assessment by dental oncology specialists blinded to background data. We used this system to elucidate the preventive effect of an ED against OM in patients with esophageal cancer receiving docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy.Patients and methodsIn this phase III, multicenter, parallel-group, controlled trial, patients consuming a normal diet orally were randomly assigned (1 : 1) to receive two cycles of DCF with (group A) or without (group B) an ED (Elental® 160 g/day). We assessed the incidence of grade ≥2 OM evaluated by two reviewers, changes in body weight, prealbumin, C-reactive protein, and DCF completion rate based on ED compliance.ResultsOf the 117 patients randomly assigned to treatment, four failed to start treatment and were excluded from the primary analysis; thus, groups A and B comprised 55 and 58 patients, respectively. There were no significant differences in background characteristics. Grade ≥2 OM was observed in eight (15%) and 20 (34%) patients in groups A and B, respectively (P = 0.0141). Changes in body weight and prealbumin during the two DCF cycles were significantly higher in group A than B (P = 0.0022 and 0.0203, respectively). During the first cycle, changes in C-reactive protein were significantly lower in group A than B (P = 0.0338). In group A (receiving ED), the DCF completion rate was 100% in patients with 100% ED compliance and 70% in patients failing ED completion (P = 0.0046).ConclusionsThe study findings demonstrate that an ED can prevent OM in patients with esophageal cancer receiving chemotherapy.
Highlights
Oral mucositis (OM) is a commonly occurring adverse event (AE) in cancer patients
OM is commonly underestimated[1] because the accuracy of OM evaluation depends on the ability to survey the oral cavity adequately using specialist instrumentation.[27]. In this EPOC 2 study, we examined whether an elemental diet (ED) could prevent OM during chemotherapy using a central review system in which blinded dental experts used photographic images of the oral cavity to ascertain OM occurrence
This technique has allowed us to eliminate bias resulting from the judgment of non-specialists and self-reported patient symptomatology
Summary
Oral mucositis (OM) is a commonly occurring adverse event (AE) in cancer patients. OM may lead to oral pain, refusal to eat, weight loss, infection, and systemic spread of local inflammation.[1]. We established a central review system for oral cavity assessment by dental oncology specialists blinded to background data. We used this system to elucidate the preventive effect of an ED against OM in patients with esophageal cancer receiving docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy. We assessed the incidence of grade !2 OM evaluated by two reviewers, changes in body weight, prealbumin, C-reactive protein, and DCF completion rate based on ED compliance. Changes in body weight and prealbumin during the two DCF cycles were significantly higher in group A than B (P 1⁄4 0.0022 and 0.0203, respectively).
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