Integrative Parenteral Nutrition in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition

Conditions
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Neoplasms, Parenteral Nutrition

Intervention / Treatment
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* Dietary Supplement: Parenteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenteral nutrition<br>Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements | Dietary Supplement: Parenteral nutrition<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase angle | Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | Change in body weight after 7 days of nutritional support | 7 days | 
| body mass index | Change in body mass index after 7 days of nutritional support | 7 days | 
| Handgrip strength | Changes in muscle strength after 7 days of nutritional support | 7 days | 
| Number of participants with treatment-related adverse events as assessed by biochemistry | Changes in biochemistry after 7 days of nutritional support | 7 days |