Feasibility study of diet counseling (DC) with oral nutritional supplements (ONS) for advanced esophageal and gastric cancer during chemotherapy (CT) or chemoradiotherapy (CRT): First report of ONS compliance from a prospective randomized controlled clinical study (DiCON study).

Abstract

17 Background: Most advanced esophageal and gastric cancer patients(pts) experience fatigue, anorexia, and may arise malnutrition and sarcopenia, for which effective treatment has not been established. Nutritional support especially protein supplementations may prevent loss of body mass related with malnutrition and sarcopenia. We therefore, conducted a prospective randomized study to explore compliance and the best available ONS intake for pts undergoing CT or CRT. Methods: Eligibility criteria included: chemo-naïve advanced gastric cancer or esophageal cancer; performance status (PS) of 0–1; pts who can eat more than as 50% as usual; age over 20 years. Pts were randomly allocated into four groups within each strata, i.e. esophageal or gastric cancer, Group A: Diet counseling (DC) only, Group B-1: DC and ONS 1 pack/day, Group B-2: DC and ONS 2 packs/day, and Group B-3: DC and ONS 3 packs/day. We use jelly type ONS which is easy to intake and include rich branched-chain amino acid. We assessed ONS compliance, the change of nutritional index (body weight, albumin, pre-albumin, and muscle mass), diet record (daily), and toxicity before CT or CRT and 14 days after administration of CT. Results: Among forty pts (11 in A, 11 in B-1,8 in B-2,10 in B-3) were enrolled from August 2017 to August 2018, median age was 64 years (range 46-81), median BMI was 20.6 (range 15-29), and 28 gastric cancer, 12 esophageal cancer. Median intake was 12 packs/2w (range 0-14), 15 packs/2w (3-28), 12 packs/2w (2-28), in B-1, B-2, and B-3 respectively. Mean compliance of ONS was 72.7%, 50.0% and 33.1%, in B-1, B-2, and B-3 respectively. There was a significant linear trend across the 3 groups (P = 0.0104). B-1 was significantly better than B-3 (P = 0.0270). There were no pts in group B-3 who could intake ONS for 14 consecutive days. Over 80% of pts in B-1 group were able to intake for 14 consecutive days. Conclusions: We found ONS 3 packs/day was clearly denied because of compliance. Choice of 1 or 2 packs/day should be determined by taking into account the total calories of foods. Clinical trial information: 000026705.