Individually compounded multi-chamber vs. standardized parenteral nutrition bags in solid tumors–A randomized clinical trial (IKF-010)

Purpose

Many cancer patients rely on home parenteral nutrition (HPN), requiring intensive nursing care and facing higher infection risks. Multi-chamber bags (MCB) for individualized HPN could reduce manipulation, enhance patient autonomy, and lower infection risks. This study (IKF-t01/PEKANNUSS) compares MCB-based HPN to traditional 2/3-chamber bags in improving patient safety and independence.

Patients and methods

Patients with metastatic or locally advanced tumors were randomized 2:1 to receive either individually compounded HPN via MCB (Arm A) or physician-choice HPN in 2/3-chamber bags (Arm B). The primary endpoint was the autonomy rate, defined as the proportion of patients self-administering ≥70 % of HPN without home care or nursing assistance. Secondary endpoints included catheter-related infections (CRIs), safety, body weight, and serum albumin levels.

Results

The study was prematurely terminated due to slow recruitment after enrolling 142 patients, with 131 evaluable in the intent-to-treat analysis. Patient autonomy was significantly improved in Arm A compared to Arm B (52 % vs. 33 %, p = 0.04), with the difference being more pronounced in patients with ECOG ≤1 (68 % vs. 42 %). The number of required injections of additive supplements into HPN bags at home was considerably lower in Arm A (11 % vs. 96 %; p < 0.01). The incidence of all-grade HPN-related adverse events (AEs) was significantly lower in Arm A (27 % vs. 55 %; p < 0.01). CRI rates were numerically lower in Arm A (13 % vs. 22 %; p = 0.22), with a more pronounced difference in patients with ECOG ≤1 (8 % vs. 25 %).

Conclusion

Individually compounded parenteral nutrition using multi-chamber bags is a safe and effective treatment option that enhances patients' capacity to self-manage their treatment.

Trial Registration

ClinicalTrials.gov, identifier NCT04105777.