Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Phase angle
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
- •Nutritional Risk Screening 2002 score ≥
- •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
Outcomes
Primary Outcomes
Phase angle
Time Frame: 7 days
Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support
Secondary Outcomes
- body weight(7 days)
- body mass index(7 days)
- Number of participants with treatment-related adverse events as assessed by biochemistry(7 days)
- Handgrip strength(7 days)