Clinical trial NCT02828150: Integrative Parenteral Nutrition in Cancer Patients
Official title: Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Parenteral Nutrition
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-07-11
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Phase angle
timeFrame: 7 days
Secondary outcomes:
measure: body weight
timeFrame: 7 days
measure: body mass index
timeFrame: 7 days
measure: Handgrip strength
timeFrame: 7 days
measure: Number of participants with treatment-related adverse events as assessed by biochemistry
timeFrame: 7 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.