Enteral Nutrition in Cancer Patients

NCT01304446 | Completed Phase 4 DMC

• 1 other identifier: 1463
• 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; pediatric

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 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.

You may not qualify if:

• Were on corticosteroid or hormonal therapy;
• Had swallowing abnormalities;
• Had parenteral or tube feeding therapy;
• Had palliative care;
• 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

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: February 25, 2011
• Last Updated: February 25, 2011

Record last verified: 2011-02