Enteral Nutrition Support in Children and Adolescents With Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Malnutrition
• Intervention / Treatment: Dietary supplement: industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 adolescents 27 were considered as mild malnutrition
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Collaborators and Investigators

• Sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): June 1, 2006

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (ESTIMATE): August 31, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 31, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Adolescent; Nutritional support.; Cancer.; Malnutrition.; Child.
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: RPM 1463/7