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

This study has been terminated.
(slow incorporation of supplemented patients, excess of control patients, and lack of one of the standard nutritional formulas.)
Sponsor:
Information provided by (Responsible Party):
MARIA PIA DE LA MAZA, University of Chile
ClinicalTrials.gov Identifier:
NCT01032512
First received: December 14, 2009
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
CANCER
Dietary Supplement: SUPPORTAN + GLUTAMINE PLUS
Dietary Supplement: NO PREOPERATIVE NUTRITION SUPPORT
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preoperative Nutrition Support in Major Oncologic Surgery

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • LENGTH OF HOSPITALIZATION [ Time Frame: 30 DAYS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • POST OPERATIVE COMPLICATIONS [ Time Frame: 60 DAYS ] [ Designated as safety issue: No ]
    Registration of all eventual surgical complication after oncologic surgery, both during hospital stay and after 30 days after hospital discharge


Enrollment: 149
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMMUNE-ENHANCING
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
600 ML OF AN ENERGY DENSE DRINK PLUS 20 G GLUTAMINE POWDER (to give 900 Kcal and 80 g protein/day)
Other Name: SUPPORTAN
Sham Comparator: CONTROL
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
Patients will be assessed and followed, but will receive no special nutritional support before the surgical procedure
Other Name: CONTROL

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency surgery
  • Time for surgery less than 8 days
  • Serum creatinine > 1.5 mg/dL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032512

Locations
Chile
Oncologic Hospital Fundacion Arturo Lopez Perez
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
University of Chile
Investigators
Principal Investigator: María Pía de la Maza, M.D. INTA, University of Chile
Study Chair: Daniel C. Bunout, M.D. INTA, University of Chile
  More Information

Additional Information:
Publications:
Responsible Party: MARIA PIA DE LA MAZA, Mrs, University of Chile
ClinicalTrials.gov Identifier: NCT01032512     History of Changes
Other Study ID Numbers: FALP001
Study First Received: December 14, 2009
Last Updated: January 12, 2012
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by University of Chile:
IMMUNE-ENHANCING
GLUTAMINE
ARGININE
OMEGA 3 FATTY ACIDS
ONCOLOGIC SURGERY
PREOPERATIVE NUTRITION

ClinicalTrials.gov processed this record on November 24, 2014