Enteral Nutrition Support in Children and Adolescents With Cancer

NCT01426750 | Completed Phase 4 DMC

• 1 other identifier: RPM 1463/7
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition; Cancer

Keywords

Nutritional support.; Cancer.; Malnutrition.; Child.; Adolescent

Study Arms (1)

IOS, TFR

EXPERIMENTAL

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

Interventions

industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren DIETARY_SUPPLEMENT

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.

IOS, TFR

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Were corticosteroid or hormonal therapy
• Swallowing abnormalities
• Parenteral or tube feeding therapy
• Palliative care and presence of non cancer-related diseases.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: August 31, 2011
• Study Start: June 1, 2002
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: August 31, 2011

Record last verified: 2011-08