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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-10-31

Brief Summary

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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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Detailed Description

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* 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.

Conditions

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Cachexia; Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization will be made at the time of study enrollment by , where patients randomly selected as even number will be included in group 1 and those selected as odd number in group 2Group 1 (G1): 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 for both sexes.

Group 2 (G2): The patient will use corticosteroids (dexamethasone) at a dose of 4 mg daily.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The outcomes assessor and investigator does not have contact with the patient or care provider at the moment of randomization and the study purpose. The investigator just apply the bioelectrical impedance analysis and helps the patient about doubts on the Quality of Life questionnaire of EORTC ( QLQ-C30)

Study Groups

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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.

Group Type EXPERIMENTAL

Nandrolone Decanoate

Intervention Type DRUG

Drug administration

Group 2: corticosteroid

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Drug administration

Interventions

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Nandrolone Decanoate

Drug administration

Intervention Type DRUG

Dexamethasone

Drug administration

Intervention Type DRUG

Other Intervention Names

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Dexamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No