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OpenTrials
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NCT Number: NCT02828150

Integrative Parenteral Nutrition in Cancer Patients

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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Key information

Conditions

Neoplasms Hyperphagia Parenteral Nutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parenteral nutrition

Dietary 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)

Primary outcomes

  1. Phase angle

    Time frame: 7 days

    Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support

Secondary outcomes

  1. body weight

    Time frame: 7 days

    Change in body weight after 7 days of nutritional support

  2. body mass index

    Time frame: 7 days

    Change in body mass index after 7 days of nutritional support

  3. Handgrip strength

    Time frame: 7 days

    Changes in muscle strength after 7 days of nutritional support

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

    Time frame: 7 days

    Changes in biochemistry after 7 days of nutritional support

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2016
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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