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Integrative Parenteral Nutrition in Cancer Patients

NCT02828150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

  • Neoplasms
  • Parenteral Nutrition

Interventions

DIETARY_SUPPLEMENT

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)

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Riccardo Caccialanza, MD · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828150 on ClinicalTrials.gov