Early elemental diet supplementation during chemotherapy improves treatment response and survival in advanced pancreatic cancer: A single-center randomized controlled trial.

[BACKGROUND & AIM] Patients with advanced pancreatic cancer often develop nutritional disorders such as malnutrition, sarcopenia, and cachexia early in the disease course. Although various interventions have been explored, no standard approach exists. This study was conducted to evaluate the efficacy of an elemental diet (ED) as nutritional support during chemotherapy.

[METHODS] In this randomized trial, patients were assigned to an ED intervention (EI) group or a normal diet (ND) group. The EI group consumed ≥1 packet/day of ED for ≥2 months. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and nutritional parameters.

[RESULTS] Sixty patients were randomized (EI: n = 30, ND: n = 30), with three withdrawals from EI. Baseline characteristics were similar. Median ED duration was 5.6 months. Over two months, BMI declined less in EI (-0.3 kg/m) than in ND (-0.6 kg/m, p = 0.044). Serum protein markers (TP, ALB, Tf, TTR) decreased significantly in ND. Handgrip strength was better preserved in EI (p = 0.010), although skeletal muscle index showed no difference (p = 0.480). First-line chemotherapy disease control rate (96.3 % vs 73.3 %, p = 0.027) and overall response rate (44.4 % vs 10.3 %, p = 0.006) were significantly higher in EI. Grade ≥3 adverse events were similar. Median PFS was 9.5 vs 6.4 months (p = 0.068), and OS was significantly longer in EI (21.4 vs 12.8 months; HR 0.55, 95 % CI 0.31-0.98; p = 0.038).

[CONCLUSION] Early ED supplementation during chemotherapy was associated with preserved nutritional status, improved treatment response, and prolonged overall survival in patients with advanced pancreatic cancer.

[CLINICAL TRIAL REGISTRATION] UMIN000028659 (https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032805).