Integrative Parenteral Nutrition in Cancer Patients

Not Applicable

Completed

• Conditions: Parenteral Nutrition; Neoplasms
• Interventions: Dietary Supplement: Parenteral nutrition

• Registration Number: NCT02828150
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of participants with treatment-related adverse events as assessed by biochemistry	7 days	Changes in biochemistry after 7 days of nutritional support
Handgrip strength	7 days	Changes in muscle strength after 7 days of nutritional support

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy