BACKGROUND AND OBJECTIVES:Patients undergoingchemotherapy often develop distressing adverse effects such as oral mucositis and diarrhea. Nutritional support with elemental diet is effective against various gastrointestinal complications and may exert protective effects against adverse effects induced by chemotherapy. To evaluate the influence of elemental diet on chemotherapy-induced oral mucositis and diarrhea, we conducted a randomized control trial in patients with esophageal cancer undergoing chemotherapy. METHODS AND STUDY DESIGN:Twenty esophageal cancer patients receivingchemotherapy with 5-fluorouracil plus cisplatin were assigned randomly to one of the following two groups: (1) receiving elemental diet with Elental (one pack per day) for 14 days and (2) not receiving Elental during chemotherapy. The severity of oral mucositis and diarrhea was graded using clinical examination by doctors and a standard questionnaireon days 1-14. RESULTS: Based on the analysis of the standard questionnaire, the distribution of the maximum severity of oral mucositis showed a statistically significant reduction in the Elental group (p=0.020), while clinical examination showed insignificant reduction but shift toward lower grade. In the Elental group, the incidence of oral mucositis (grade >=2) reduced consistently and the median grade was lower at all-time points. Regarding diarrhea, no difference was observed between the two groups based on the analysis of the standard questionnaire and clinical examination results. CONCLUSIONS: This study illustrates the effectiveness of oral elemental diet in preventing oral mucositis during chemotherapy. This is a preliminary report and further study with larger patients groups should be devoted to optimization of efficacy.
RCT Entities:
BACKGROUND AND OBJECTIVES:Patients undergoing chemotherapy often develop distressing adverse effects such as oral mucositis and diarrhea. Nutritional support with elemental diet is effective against various gastrointestinal complications and may exert protective effects against adverse effects induced by chemotherapy. To evaluate the influence of elemental diet on chemotherapy-induced oral mucositis and diarrhea, we conducted a randomized control trial in patients with esophageal cancer undergoing chemotherapy. METHODS AND STUDY DESIGN: Twenty esophageal cancerpatients receiving chemotherapy with 5-fluorouracil plus cisplatin were assigned randomly to one of the following two groups: (1) receiving elemental diet with Elental (one pack per day) for 14 days and (2) not receiving Elental during chemotherapy. The severity of oral mucositis and diarrhea was graded using clinical examination by doctors and a standard questionnaireon days 1-14. RESULTS: Based on the analysis of the standard questionnaire, the distribution of the maximum severity of oral mucositis showed a statistically significant reduction in the Elental group (p=0.020), while clinical examination showed insignificant reduction but shift toward lower grade. In the Elental group, the incidence of oral mucositis (grade >=2) reduced consistently and the median grade was lower at all-time points. Regarding diarrhea, no difference was observed between the two groups based on the analysis of the standard questionnaire and clinical examination results. CONCLUSIONS: This study illustrates the effectiveness of oral elemental diet in preventing oral mucositis during chemotherapy. This is a preliminary report and further study with larger patients groups should be devoted to optimization of efficacy.
Authors: Alejandro Sanz-Paris; María Martinez-García; Javier Martinez-Trufero; Julio Lambea-Sorrosal; Fernando Calvo-Gracia; María Elena López-Alaminos Journal: Nutrients Date: 2019-08-13 Impact factor: 5.717