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CompletedNCT02828150Updated May 1, 2025

Integrative Parenteral Nutrition in Cancer Patients

An interventional study of Parenteral nutrition in Neoplasms and Parenteral Nutrition, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Neoplasms
  • Parenteral Nutrition
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In context

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    Parenteral nutrition

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

    Dietary Supplement: Parenteral nutrition

Interventions

  • Dietary supplementParenteral 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)

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What researchers measure

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

    Time frame: 7 days

Secondary outcomes

  1. body weight

    Change in body weight after 7 days of nutritional support

    Time frame: 7 days

  2. body mass index

    Change in body mass index after 7 days of nutritional support

    Time frame: 7 days

  3. Handgrip strength

    Changes in muscle strength after 7 days of nutritional support

    Time frame: 7 days

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

    Changes in biochemistry after 7 days of nutritional support

    Time frame: 7 days

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Study locations

1 site
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, 27100, Italy
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References and documents

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. PubMed 25768953 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02828150
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborators
Baxter Healthcare Corporation
Responsible party
Riccardo Caccialanza (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Jul 11, 2016
Start date
Jul 2016
Primary completion
Dec 2017
Completion
Dec 2017
Last update
May 1, 2025

Study contacts

Riccardo Caccialanza, MD
principal investigator · Fondazione IRCCS Policlinico San Matteo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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