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CompletedNCT03263520Updated Feb 26, 2019

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

An interventional study of Nandrolone Decanoate and Dexamethasone in Cachexia; Cancer, sponsored by Hospital Erasto Gaertner. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Hospital Erasto Gaertner · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Feb 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description
  • 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.
02

Conditions studied

  • Cachexia; Cancer
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's enrollment of 60 is below the median of 74 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Hospital Erasto Gaertner is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group 1: nandrolone and corticosteroid

    the patient will receive an application of anabolic nandrolone decanoate at a dose of 50 mg (males) and 25 mg (females), intra-muscular form, in the first and fifteenth days. In addition to the anabolic steroid, the patient will use corticosteroids (dexamethasone) at home at a dose of 4 mg daily by mouth on the morning for both sexes for 30 days.

    Drug: Nandrolone Decanoate

  • Active comparator
    Group 2: corticosteroid

    Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days

    Drug: Dexamethasone

Interventions

06

What researchers measure

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

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

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

  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)

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

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

  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

    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

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

Secondary outcomes

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

    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)

    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.

07

Study locations

1 site
  • Hospital Erasto Gaertner
    Curitiba, Paraná 81520060, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03263520
Lead sponsor
Hospital Erasto Gaertner
Responsible party
Sponsor
First posted
Aug 28, 2017
Start date
Feb 2016
Primary completion
Aug 30, 2017
Completion
Oct 31, 2017
Last update
Feb 26, 2019

Study contacts

Vinicius B Preti, MD
principal investigator · Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Nandrolone Decanoate

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