Enteral Nutrition in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial

Conditions
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Malnutrition, Cancer

Intervention / Treatment
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* Dietary Supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOS, TFR<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional support, Cancer, Malnutrition, Child, Adolescent, pediatric