Enteral Nutrition in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01304446
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Information provided by:
Grupo de Apoio ao Adolescente e a Crianca com Cancer

Brief Summary:

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 or disease Intervention/treatment Phase
Malnutrition Cancer Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial

Arm Intervention/treatment
Experimental: 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.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Were on corticosteroid or hormonal therapy;
  • Had swallowing abnormalities;
  • Had parenteral or tube feeding therapy;
  • Had palliative care;
  • Presence of non cancer-related diseases.

Responsible Party: Adriana Garófolo, Nutrition Coordinator Identifier: NCT01304446     History of Changes
Other Study ID Numbers: 1463
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

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

Additional relevant MeSH terms:
Nutrition Disorders