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Enteral Nutrition in Cancer Patient

This study has been completed.
Sponsor:
Information provided by:
Grupo de Apoio ao Adolescente e a Crianca com Cancer
ClinicalTrials.gov Identifier:
NCT01302509
First received: October 30, 2008
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Condition Intervention Phase
Malnutrition
Cancer
Pediatric
 Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grupo de Apoio ao Adolescente e a Crianca com Cancer:

Arms Assigned Interventions
Active Comparator: IOS, TFR
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
 Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
The oral and tube supplement offered was Nutren Jr® (for patients aged 1 - 9 years) or Nutren 1.0- Nestlé Clinical Nutrition-Brazil (for those aged 10 years or over). This supplement was a whole powder formulation that presented a macro composition of 52% carbohydrates, 12% proteins and 36% lipids. Its vitamins were A, D, E, K, B complex, biotin and choline; its trace elements were iron, copper, zinc, manganese, selenium, chromium and molybdenum; its macroelements were potassium, calcium, sodium, chlorine, iodine, magnesium and phosphorus; and it contained taurine and L-carnitine presenting 1.0 kcal/ml.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Were chemotherapy, age above one year and malnutrition. A z-score of weight for height (zW/H) < -1.0 to -2.0 in children26 and ≥ 5th to < 15th of body mass index (BMI) in adolescents27 were considered as mild malnutrition; and a zW/H < -2.0 in children and < 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: < 18.5 mild and < 17 severe malnutrition.

Exclusion Criteria:

  • Were corticosteroid or hormonal therapy, swallowing abnormalities, parenteral or tube feeding therapy, palliative care and presence of non cancer-related diseases.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Adriana Garófolo, Nutrition Coordinator
ClinicalTrials.gov Identifier: NCT01302509     History of Changes
Other Study ID Numbers: 1968
Study First Received: October 30, 2008
Last Updated: February 22, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Grupo de Apoio ao Adolescente e a Crianca com Cancer:
Nutritional support.
Cancer.
Malnutrition.
Child.
Adolescent

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013