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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Individually compounded multi-chamber vs. standardized parenteral nutrition bags in solid tumors-A randomized
Thorsten Oliver Goetze1, Ralf-Dieter Hofheinz2, Ingeborg Roetzer3
1Hospital Northwest, University Cancer Center Frankfurt, Frankfurt, Germany; The Frankfurt Institute of Clinical Cancer Research IKF GmbH, Frankfurt, Germany.
Insights
Multi-chamber bags (MCB) for home parenteral nutrition (HPN) significantly improved patient autonomy and reduced adverse events compared to traditional bags. This approach enhances self-management for cancer patients receiving HPN.
Area of Science:
- Oncology
- Clinical Nutrition
- Patient Care
Background:
- Cancer patients often require home parenteral nutrition (HPN), posing risks of infection and dependency on nursing care.
- Multi-chamber bags (MCB) offer a potential solution for individualized HPN, aiming to reduce handling, improve patient autonomy, and decrease infection risks.
Purpose of the Study:
- To compare the efficacy and safety of individually compounded HPN using MCB versus traditional 2/3-chamber bags.
- To evaluate the impact on patient autonomy, catheter-related infections (CRIs), and overall safety in cancer patients.
Main Methods:
- A randomized controlled trial (IKF-t01/PEKANNUSS) comparing MCB-based HPN (Arm A) to traditional HPN (Arm B) in patients with advanced tumors.
- Primary endpoint: autonomy rate (self-administration of ≥70% HPN). Secondary endpoints: CRIs, safety, body weight, and albumin levels.
Main Results:
- Patient autonomy significantly increased with MCB (52% vs. 33%, p=0.04), especially in patients with ECOG ≤1 (68% vs. 42%).
- MCB significantly reduced the need for home additive injections (11% vs. 96%, p<0.01) and overall HPN-related adverse events (27% vs. 55%, p<0.01).
- Numerically lower CRI rates were observed with MCB (13% vs. 22%), with a more pronounced difference in patients with ECOG ≤1 (8% vs. 25%).
Conclusions:
- Individually compounded HPN using MCB is a safe and effective treatment.
- MCB enhances patients' ability to self-manage their HPN, improving independence and safety.
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.
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