Spots Global Cancer Trial Database for Early IntraVenous Administration of Nutritional Support

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Trial Identification

Brief Title: Early IntraVenous Administration of Nutritional Support

Official Title: Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy

Study ID: NCT03949907

Conditions

Cancer of Stomach

GastroEsophageal Cancer

Interventions

Nutritional counseling alone

Early supplemental parenteral nutrition plus nutritional counseling

Study Description

Brief Summary: The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

Detailed Description: Although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. It is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. International guidelines suggest that parenteral nutrition (PN) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. Although recent trials suggest that supplemental PN (SPN) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early SPN in cancer patients at nutritional risk receiving first-line chemotherapy.