Royal Surrey NHS Foundation Trust, Egerton Road, Guildford, GU2 7XX, United Kingdom.
Surrey Clinical Trials Unit, School of Biosciences, University of Surrey, Egerton Road, Guildford, GU2 7XP, United Kingdom.
Support Care Cancer. 2024 Aug 2;32(8):567. doi: 10.1007/s00520-024-08709-7.
Nutrition support in inoperable bowel obstruction (IBO) remains challenging. Parenteral nutrition (PN) is recommended if the prognosis is > 2 months. An elemental diet (ED) is licensed for strictures in Crohn's disease but has not been used in malignant bowel obstruction. The aim of this study was to evaluate the use of ED in patients with IBO and provide a proof of concept of ED as an acceptable feeding option.
This was a mixed-methods single-arm feasibility study. The primary endpoint was to provide a 'proof of concept' of ED as an acceptable feeding option for patients with IBO. Secondary endpoints included taste acceptability, incidences of vomiting and pain, the proportion of women who tolerated ED, the number of cartons drunk, quality of life (QOL) and the number of women treated with chemotherapy. Patients (> 18 years) with CT-confirmed IBO who could tolerate 500 ml of liquid in 24 h remained on the trial for 2 weeks.
A total of 29 patients were recruited; of those, 19 contributed to the analysis for the primary endpoint; 13 (68.4%) participants tolerated the ED; 26 patients contributed to MSAS and EORTC QLQ questionnaires at baseline to allow for the assessment of symptoms. At the start of the study, 18 (69%) of patients experienced vomiting, reducing to 4 (25%) by the end of day 15 of the study; 24 (92%) of patients reported pain at consent, reducing to 12 (75%) by the end of day 15. QOL scores improved from 36.2 (95% CI 27.7-44.7) at baseline to 53.1 (95% CI 40.3-66) at the end of day 15; 16 (84%) participants commenced chemotherapy within the first week of starting ED. The number of cartons across all participants showed a median of 1.3 cartons per day (range 0.8 to 2.5).
ED is well tolerated by patients with IBO caused by gynaecological malignancies and may have a positive effect on symptom burden and QOL.
无法手术的肠梗阻(IBO)的营养支持仍然具有挑战性。如果预后超过 2 个月,则建议使用肠外营养(PN)。要素饮食(ED)被批准用于克罗恩病狭窄,但尚未用于恶性肠梗阻。本研究的目的是评估 ED 在 IBO 患者中的应用,并提供 ED 作为可接受的喂养选择的概念验证。
这是一项混合方法的单臂可行性研究。主要终点是提供 ED 作为 IBO 患者可接受的喂养选择的概念验证。次要终点包括口感可接受性、呕吐和疼痛的发生率、能够耐受 ED 的女性比例、饮用的纸盒数量、生活质量(QOL)和接受化疗的女性数量。CT 证实的 IBO 患者,能够在 24 小时内耐受 500ml 液体,在试验中继续治疗 2 周。
共招募了 29 名患者;其中,19 名患者对主要终点进行了分析;13 名(68.4%)参与者耐受 ED;26 名患者在基线时对 MSAS 和 EORTC QLQ 问卷进行了评估,以评估症状。在研究开始时,18 名(69%)患者出现呕吐,到研究第 15 天结束时减少到 4 名(25%);24 名(92%)患者在同意时报告疼痛,到研究第 15 天结束时减少到 12 名(75%)。生活质量评分从基线时的 36.2(95%CI 27.7-44.7)提高到第 15 天的 53.1(95%CI 40.3-66);16 名(84%)参与者在开始 ED 治疗的第一周内开始化疗。所有参与者的纸盒数量中位数为每天 1.3 盒(范围为 0.8 至 2.5)。
ED 被妇科恶性肿瘤引起的 IBO 患者很好地耐受,可能对症状负担和 QOL 产生积极影响。