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Completed

NCT Number: NCT03263520

Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer

Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in patients with tumors in the high gastro-intestinal tract, liver, pancreas and bile ducts in palliative treatment.

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Key information

Conditions

Cachexia; Cancer Body Weight Body Weight Changes Cachexia Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520060, Brazil

About this study

  • Compare muscle mass values obtained before and after the use of anabolic steroids upon assessment by bioelectrical impedance analysis (BIA).
  • Compare the anabolic effect on quality of life (QLo) of the patient before and after the use of anabolic steroids.
  • Compare data from laboratory tests such as complete blood count, albumin, C reactive protein and transferrin with drug intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cancer patients above 18 years old.
  • Patients with tumors in the high gastro-intestinal, hepatobiliary and pancreatic tracts in palliation.
  • Patients able to undergo BIA.
  • Malnourished patients as per the subjective global assessment produced by the patient (ASG-PPP) and whose score is greater than nine.
  • Patients who agree to participate in the study.

Exclusion criteria

  • Patients with malignant tumors of other metachronous or synchronous location except nonmelanoma skin tumor
  • Patients with chronic renal failure.
  • Patients on diuretics, recent or chronic.
  • Patients on appetite stimulants and anabolic agents.
  • Patients using pacemakers, which can interfere with the results of BIA

Treatment and study plan

Nandrolone Decanoate

Drug

Drug administration

Other names: Dexamethasone

Dexamethasone

Drug

Drug administration

Primary outcomes

  1. Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients

    Time frame: After 30 days, the values will be compared to those obtained on the first consultant.

    Evaluate the BMI ( body mass index)- the weight in kilograms and the height in centimeters and BMI in Kg/ m2.

  2. Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients by bioimpedance analysis ( BIA)

    Time frame: After 30 days, the values will be compared to those obtained on the first consultant.

    Evaluate the BIA (biometrical impedance analysis)trough the reactance and resistance in ohms and the phase angle in degree.

  3. ompare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients trough quality of life assessment

    Time frame: After 30 days, the values will be compared to those obtained on the first consultant.

    Evaluate quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnare Core 30 ( QLQ-C30), version 3.0 . The values are expressed as a percentage

Secondary outcomes

  1. Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.

    Time frame: After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.

    The complete blood count will be expressed in millions by cubic milimiter( millions/mm3) , albumin in grams per deciliter (g/dL), C reactive protein in milligrams per deciliter (mg/dL), transferrin in milligrams per deciliter (mg/dL)

Sponsors and collaborators

Lead sponsor

Hospital Erasto Gaertner

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2017
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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