NCT02828150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

June 30, 2016

Last Update Submit

April 29, 2025

Conditions

NeoplasmsParenteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • body weight

    7 days

  • body mass index

    7 days

  • Handgrip strength

    7 days

  • Number of participants with treatment-related adverse events as assessed by biochemistry

    7 days

Study Arms (1)

Parenteral nutrition

EXPERIMENTAL

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

Dietary Supplement: Parenteral nutrition

Interventions

Parenteral nutritionDIETARY_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)

Parenteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Ongoing artificial nutrition before hospitalization
  • Eastern Cooperative Oncology Group performance status \>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25768953BACKGROUND

MeSH Terms

Conditions

NeoplasmsHyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Riccardo Caccialanza, MD

    Fondazione IRCCS Policlinico San Matteo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

IT(1)