Nutritional education and counseling program for adult cancer patients during radiotherapy: a cluster-randomized clinical trial

PurposeNutrition education andcounseling is the first-line approach in nutritional support for adult cancer patients; however, it is not well implemented in many clinical settings. This study aims to determine the effect of an evidence-based nutrition education and counseling (NEC) program on nutrition status among cancer patients receiving radiotherapy.Subjects/methodsThis cluster-randomized clinical trial enrolled cancer patients receiving radiotherapy from ten radiotherapy units in three hospitals. Randomization was conducted at the unit level (five units into the NEC group and five units into the usual care group). The primary outcome was nutrition status after radiotherapy measured by the Patient-Generated Subjective Global Assessment (PG-SGA). Secondary outcomes included nutrition-related blood biomarkers after radiotherapy and the use of artificial nutrition and treatment interruption during radiotherapy.ResultsA total of 468 patients were enrolled (241 in the NEC and 227 in the usual care group); 196 patients were female with a mean age (SD) of 59.8 (11.9). No difference was found between the NEC and usual care groups in nutrition status and blood biomarkers at baseline. After radiotherapy, patients in the NEC group had lower PG-SGA scores (5.6 vs 6.9; MD = −1.3, p < 0.001) and lower malnutrition rate (56.0% vs 70.5%; OR = 0.5; p = 0.004) compared with the usual care group. The usages of artificial nutrition and treatment interruption during radiotherapy and the level of blood biomarkers after radiotherapy did not differ between groups.ConclusionsNutrition education and counseling is an effective approach in reducing malnutrition and can be generalized to multiple radiotherapy settings.Registered under ClinicalTrails.gov Identifier no.None.