Integrative Parenteral Nutrition in Cancer Patients

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828150
• Other study ID #: 2015013559
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: December 1, 2017
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Parenteral Nutrition

Intervention

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)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	Baxter Healthcare Corporation

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	body weight	Change in body weight after 7 days of nutritional support	7 days
Secondary	body mass index	Change in body mass index after 7 days of nutritional support	7 days
Secondary	Handgrip strength	Changes in muscle strength after 7 days of nutritional support	7 days
Secondary	Number of participants with treatment-related adverse events as assessed by biochemistry	Changes in biochemistry after 7 days of nutritional support	7 days