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

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ClinicalTrials.gov Identifier: NCT01032512
Recruitment Status : Withdrawn (impossibility to include patients in the study)
First Posted : December 15, 2009
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
MARIA PIA DE LA MAZA, University of Chile

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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Nutrition Support in Major Oncologic Surgery
Actual Study Start Date : December 2009
Primary Completion Date : December 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. LENGTH OF HOSPITALIZATION [ Time Frame: 30 DAYS ]

Secondary Outcome Measures :
  1. POST OPERATIVE COMPLICATIONS [ Time Frame: 60 DAYS ]
    Registration of all eventual surgical complication after oncologic surgery, both during hospital stay and after 30 days after hospital discharge



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by MARIA PIA DE LA MAZA, University of Chile:
IMMUNE-ENHANCING
GLUTAMINE
ARGININE
OMEGA 3 FATTY ACIDS
ONCOLOGIC SURGERY
PREOPERATIVE NUTRITION