Clinical Benefits of Preoperative Nutrition Support With Enteral Immune-enhancing Formulas in Surgical Oncology

NCT01032512 | Withdrawn Phase 3

• 1 other identifier: FALP001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

After surgical treatment, numerous trials using early postoperative enteral or parenteral nutritional support have been attempted, in order to reduce morbidity and mortality. Although it is difficult to compare among heterogeneous interventions, most of them have not been successful, a fact generally attributed to the timing of the intervention. On the other hand, nutrients that become "conditionally essential" under certain stressful circumstances, the so called nutraceuticals, have been incorporated into nutritional formulations. Both facts have prompted the idea of pre or perioperative nutrition support, using specific formulations called "immune enhancing" formulas, containing arginine, nucleotides, glutamine and omega3 fatty acids in varying concentrations. The provision of these nutraceuticals prior and early after the surgical, and particularly in oncologic surgery, theoretically permits to obtain adequate circulating and tissue concentrations for the moment when they are most needed. Exclusive postoperative provision of these substances would not be able to replenish depots and provide them for an adequate immune response and wound healing after surgery. However, regarding the preoperative approach, it is still not know which patients benefit more (less or more severely malnourished), which specific nutrient(s) are responsible for the positive effects, and the precise timing these nutrients should be provided. The present study aims to demonstrate that immune-enhancing formulas are superior to standard enteral products in reducing postoperative nutrition-related complications.

Conditions

CANCER

Keywords

IMMUNE-ENHANCING; GLUTAMINE; ARGININE; OMEGA 3 FATTY ACIDS; ONCOLOGIC SURGERY; PREOPERATIVE NUTRITION

Outcome Measures

Primary Outcomes (1)

• LENGTH OF HOSPITALIZATION

  30 DAYS

Secondary Outcomes (1)

• POST OPERATIVE COMPLICATIONS

  60 DAYS

Study Arms (2)

IMMUNE-ENHANCING

EXPERIMENTAL

40 patients will be instructed to consume 600 ml of the special "immune-enhancing" formula plus 20 g glutamine (Supportan R + Glutamine plus R, which contain 900 Kcal and 60 g protein/day, with 24.4 g glutamine, 2,2 g arginine and 4.4 g of omega 3 fatty acids, in a lower volume due to its higher energy density).

Dietary Supplement: SUPPORTAN + GLUTAMINE PLUS

CONTROL

SHAM COMPARATOR

40 patients that do not agree to participate, do not have enough time before the operation, do not tolerate the product and/or drink less than 100 cc/day.

Dietary Supplement: NO PREOPERATIVE NUTRITION SUPPORT

Interventions

SUPPORTAN + GLUTAMINE PLUS DIETARY_SUPPLEMENT

600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)

Also known as: SUPPORTAN

IMMUNE-ENHANCING

NO PREOPERATIVE NUTRITION SUPPORT DIETARY_SUPPLEMENT

Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure

Also known as: CONTROL

CONTROL

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Every patient submitted for major digestive oncologic surgery in the next 8 to 10 days
• Agrees to participate
• Tolerates formula

You may not qualify if:

• Emergency surgery
• Time for surgery less than 8 days
• Serum creatinine \> 1.5 mg/dL

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Oncologic Hospital Fundacion Arturo Lopez Perez

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• August DA, Huhmann MB; American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support therapy during adult anticancer treatment and in hematopoietic cell transplantation. JPEN J Parenter Enteral Nutr. 2009 Sep-Oct;33(5):472-500. doi: 10.1177/0148607109341804. No abstract available.

  PMID: 19713551 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• María Pía de la Maza, M.D.

  INTA, University of Chile

  PRINCIPAL INVESTIGATOR

• Daniel C. Bunout, M.D.

  INTA, University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

CL (1)