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

Not Applicable

Completed

• Conditions: Cachexia; Cancer
• Interventions: Drug: Nandrolone Decanoate; Drug: Dexamethasone

• Registration Number: NCT03263520
• Lead Sponsor: Hospital Erasto Gaertner

Brief 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.

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Primary Completion: 2017-08-30
• Study Completion: 2017-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: nandrolone and corticosteroid	Nandrolone Decanoate	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 2: corticosteroid	Dexamethasone	Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days

Primary Outcome Measures

Name	Time	Method
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)	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.
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients	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.
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	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital Erasto Gaertner; 🇧🇷 Curitiba, Paraná, Brazil