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Enteral Nutrition in Cancer Patient

Primary Purpose

Malnutrition, Cancer, Pediatric

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
Sponsored by
Grupo de Apoio ao Adolescente e a Crianca com Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutritional support., Cancer., Malnutrition., Child., Adolescent

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 adolescents27 were considered as mild malnutrition; and 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    IOS, TFR

    Arm Description

    industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2008
    Last Updated
    February 22, 2011
    Sponsor
    Grupo de Apoio ao Adolescente e a Crianca com Cancer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01302509
    Brief Title
    Enteral Nutrition in Cancer Patient
    Official Title
    Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Grupo de Apoio ao Adolescente e a Crianca com Cancer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition, Cancer, Pediatric
    Keywords
    Nutritional support., Cancer., Malnutrition., Child., Adolescent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    IOS, TFR
    Arm Type
    Active Comparator
    Arm Description
    industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren 1.0 or Jr (Nestlé-Clinical Nutrition).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 adolescents27 were considered as mild malnutrition; and 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.

    12. IPD Sharing Statement

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