Early IntraVenous Administration of Nutritional Support (IVANS)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Terminated

Conditions: Cancer of Stomach; GastroEsophageal Cancer

Treatments: Other: Nutritional counseling alone; Other: Early supplemental parenteral nutrition plus nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03949907

20190028466

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer;
• no previous chemotherapy for metastatic disease;
• indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
• measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
• presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3);
• availability of permanent venous access (Port, Groshong, PICC);
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
• signed informed consent.

Exclusion criteria

• age <18 years
• ECOG performance status >2
• indication to complete artificial nutrition support (totally compromised spontaneous food-intake)
• contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention)
• availability of jejunostomy for nutritional purposes
• ongoing home artificial nutrition
• unfeasible home parenteral nutrition for social/familial reasons
• absence of caregivers
• patients refusal

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Nutritional counseling alone

Other group

Description:

Nutritional counseling consists of a personalized dietary prescription with regular consultation by a registered dietitian and telephone interviews, as well as of the use of oral nutritional supplements, when necessary.

Treatment:

Other: Nutritional counseling alone

Supplemental parenteral nutrition plus nutritional counseling

Experimental group

Description:

Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.

Treatment:

Other: Early supplemental parenteral nutrition plus nutritional counseling