Integrative Parenteral Nutrition in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Neoplasms Parenteral Nutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parenteral nutrition

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

Group Type EXPERIMENTAL

Parenteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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)

Interventions

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Parenteral 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)

Intervention Type DIETARY_SUPPLEMENT

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