Background Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been recommended at the earliest opportunity in malnourished cancer patients. The limited available evidence on the efficacy of SPN in gastrointestinal cancer patients is positive, particularly with regards to QoL, body composition, and energy intake, but the evidence on survival is still scanty. Furthermore, studies regarding the early administration of SPN in combination with nutritional counseling from the beginning of first-line chemotherapy (CT) are lacking. We hypothesize that early systematic SPN in combination with nutritional counseling (NC), compared with NC alone, can benefit patients with previously untreated metastatic gastric cancer at nutritional risk undergoing first-line CT. Methods The aim of this pragmatic, multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial is to evaluate the efficacy in terms of survival, weight maintenance, body composition, QoL and feasibility of cancer therapy of early systematic SNP. This is in combination with NC, compared with NC alone, in treatment-naïve metastatic gastric cancer patients at nutritional risk undergoing first-line CT. Discussion Malnutrition in oncology remains an overlooked problem. Although the importance of SPN in gastrointestinal cancer patients has been acknowledged, no studies have yet evaluated the efficacy of early SPN in metastatic gastric patients undergoing CT. The present study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early intensive nutritional support in cancer patients undergoing CT. This study could stimulate further large randomized trials in different cancer types, potentially resulting in the improvement of supportive care quality. Trial registration This study is registered on ClinicalTrials.gov: NCT03949907.

中文翻译：

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有营养风险的转移性胃癌患者接受一线化疗的早期静脉内营养支持 (IVANS)：务实、随机、多中心、临床试验的研究方案。

背景 营养不良在癌症患者中很常见，特别是在受胃肠道恶性肿瘤影响的患者中，并且会对治疗耐受性、生存率、功能状态和生活质量 (QoL) 产生负面影响。营养支持，包括补充肠外营养 (SPN)，已被建议尽早用于营养不良的癌症患者。关于 SPN 对胃肠癌患者疗效的有限可用证据是积极的，特别是在生活质量、身体成分和能量摄入方面，但关于生存的证据仍然很少。此外，缺乏从一线化疗 (CT) 开始就早期给予 SPN 与营养咨询相结合的研究。我们假设早期系统性 SPN 与营养咨询 (NC) 相结合，与单独使用 NC 相比，可以使先前未治疗的有营养风险的转移性胃癌患者接受一线 CT 治疗。方法 这项务实、多中心、随机 (1:1)、平行组、开放标签、对照临床试验的目的是评估患者在生存、体重维持、身体成分、生活质量和癌症治疗可行性方面的疗效。早期系统性 SNP。与单独使用 NC 相比，这与 NC 联合用于有营养风险且接受一线 CT 的初治转移性胃癌患者。讨论 肿瘤学中的营养不良仍然是一个被忽视的问题。尽管 SPN 在胃肠癌患者中的重要性已得到承认，但尚未有研究评估早期 SPN 在接受 CT 的转移性胃患者中的疗效。本研究，它保证了根据最近的指南和建议向所有入组患者提供早期营养评估和支持，这可能是早期强化营养支持在接受 CT 的癌症患者中临床有效性的首批证据之一。这项研究可能会刺激针对不同癌症类型的进一步大型随机试验，从而有可能提高支持性护理质量。试验注册 本研究已在 ClinicalTrials.gov 上注册：NCT03949907。这项研究可能会刺激针对不同癌症类型的进一步大型随机试验，从而有可能提高支持性护理质量。试验注册 本研究已在 ClinicalTrials.gov 上注册：NCT03949907。这项研究可能会刺激针对不同癌症类型的进一步大型随机试验，从而有可能提高支持性护理质量。试验注册 本研究已在 ClinicalTrials.gov 上注册：NCT03949907。