Integrative Parenteral Nutrition in Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Parenteral Nutrition
• Intervention / Treatment: Dietary supplement: Parenteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parenteral nutrition; Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Caccialanza R, Cereda E, Klersy C, Bonardi C, Cappello S, Quarleri L, Turri A, Montagna E, Iacona I, Valentino F, Pedrazzoli P. Phase angle and handgrip strength are sensitive early markers of energy intake in hypophagic, non-surgical patients at nutritional risk, with contraindications to enteral nutrition. Nutrients. 2015 Mar 11;7(3):1828-40. doi: 10.3390/nu7031828.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015013559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided