Neoplasms, Parenteral Nutrition
Conditions
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.
Interventions
DIETARY_SUPPLEMENTParenteral nutrition
Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements. Energy: resting energy expenditure \[Harris-Benedict\] multiplied by a factor of 1.5. Protein: 1.5 g/kg/day. In obese patients (BMI \>30 kg/m2) support will be calculated on ideal body weight (BMI=23 kg/m2)
Sponsors
Baxter Healthcare Corporation
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase angle | 7 days | Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 7 days | Change in body weight after 7 days of nutritional support |
| body mass index | 7 days | Change in body mass index after 7 days of nutritional support |
| Handgrip strength | 7 days | Changes in muscle strength after 7 days of nutritional support |
| Number of participants with treatment-related adverse events as assessed by biochemistry | 7 days | Changes in biochemistry after 7 days of nutritional support |
Countries
Italy
Outcome results
None listed