Enteral Nutrition Support in Children and Adolescents With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426750
• Other study ID #: RPM 1463/7
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: August 29, 2011
• Start date: June 2002
• Est. completion date: June 2006

Study information

• Verified date: August 2011
• Source: Grupo de Apoio ao Adolescente e a Crianca com Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Apoio ao Adolescente e a Crianca com Cancer