Triticum vulgare mouthwashes (TVM) for patients (pts) with oral mucositis (OM) induced by chemotherapy and chemoradiotherapy (ONCOLGroup study)

Abstract

e20570 Background: OM is a frequent complication of cancer therapy in Colombia. Triticum vulgare has been reported to effectively treat mucosal and skin disturbances. Methods: To evaluate the safety and efficacy of TVM for the control of OM induced by chemoradiotherapy in pts with head and neck cancer (HNC) and by chemotherapy in pts with haematological malignancies (HM). Thirty-one pts received TVM delivered in a spray four times daily to the whole oral cavity until the OM being resolved. The primary endpoint was the OM grade evaluated daily using the Nebraska scale (NS). Secondary endpoints were OM duration, weight loss, pain and TVM tolerance; the latter two were evaluated using a visual analogue scale (VAS). Results were compared with data from 42 pts with OM treated with saline mouthwashes (SM) in a previous clinical trial. Results: Nineteen pts had HM and 12 had HNC; those with HM developed OM on day 9 of chemotherapy (range, 7–14), whilst those having HNC did so towards day 17 of chemoradiation (range, 13–26). Using NS 38% of pts developed GI OM, 46% GII OM and 16% GIII OM. Moderate and severe OM occurred more frequently amongst HNC pts (8 vs 1, p = 0.047), mean OM duration in HNC pts was 12±4.5 days, whilst it was 7 ±3 days (p = 0.047) in pts with HM. Median OM duration in pts treated with TVM was 5.4 days (range, 2–9) vs 7 days (range 1–17) for pts treated with SM (p = 0.048). TVM appears to reduce weight loss, especially in pts with HNC (p = 0.058); however, no changes were documented regarding saliva characteristics and production, mucosal bleeding and voice properties. Evaluation of pain did not reveal differences between the groups (VAS 5.5 for the TV compared to VAS 6.2 for SM; p = 0.27) but the proportion of pts suffering from pain VAS≥7 differed between both populations (8% TV vs 23% SM; p = 0.043). There are no significant adverse events with TVM. Conclusions: TVM is safe and has therapeutic activity against OM. Further phase III study is needed to confirm these results. No significant financial relationships to disclose.