University of Surrey, Guildford, United Kingdom
Agnieszka Michael , Eleanor Smith , Adele Hugg , Thomas Kilpatrick
Background: Inoperable bowel obstruction (IBO) occurs in up to 50% of patients diagnosed with ovarian cancer. Nutrition support for patients with IBO is challenging. Parenteral feeding (PN) is the recommended route for patients with a prognosis of > 2 months, however there is little evidence that it improves quality of life and the cost of it is very high . If PN is not available patients are frequently discharged home from hospital with sips of clear fluids only. Management of inoperable bowel obstruction remains a major challenge and clear guidelines are needed. Elemental diet (ED) is a liquid diet that contains proteins in the form of amino acids, fats in the form of medium chain triglycerides, vitamins and trace minerals. EDs are almost completely absorbed in the upper small intestine Methods: The primary objective of the study is to establish if ED can be used as an alternative to home PN in patients with IBO by providing a ‘proof of concept’ of ED as an acceptable and useful feeding option. The secondary aim is to examine the impact of ED on quality of life. The primary endpoints of the study are taste acceptability (graded 1-5 on a purposely designed Elemental Diet data collection chart), incidence of vomiting and incidence of pain. The secondary endpoints include the number of women who can tolerate ED and can subsequently be treated with palliative chemotherapy (as per standard of care), the number of patients alive at the end of the study, quality of life and nutritional intake. This is a mixed-method single arm feasibility study of 34 patients diagnosed with IBO and who can tolerate 500ml of liquid. Patients are provided with ED and followed-up for 2 weeks. Patients’ symptoms and quality of life are assessed using the Memorial Symptoms Assessment Scale (MSAS) and EORTC Quality of Life QLQ-C30 questionnaire. As this is a feasibility study to evaluate whether ED is an acceptable intervention for patients with IBO, recruiting 25 patients into the study will provide an answer to the question. As the prognosis is poor in this cohort we assumed 25% attrition rate 8 out of 34 patients have been recruited and the recruitment continues. Clinical trial information: ISRCTN16862540.
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