Integrative Parenteral Nutrition in Cancer Patients

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Neoplasms; Parenteral Nutrition

Treatments: Dietary Supplement: Parenteral nutrition

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02828150

2015013559

Details and patient eligibility

About

Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.

International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.

Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
• Nutritional Risk Screening 2002 score ≥3.
• Expected duration of parenteral nutrition ≥7 days
• Availability to planned measurements
• Contraindication to enteral nutrition support
• Written informed consent

Exclusion criteria

• Age < 18 years
• Ongoing artificial nutrition before hospitalization
• Eastern Cooperative Oncology Group performance status >2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

Parenteral nutrition

Experimental group

Description:

Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements

Treatment:

Dietary Supplement: Parenteral nutrition