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.

Study Overview

• Status: Completed
• Conditions: Cachexia; Cancer
• Intervention / Treatment: Drug: Nandrolone Decanoate; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81520060
      • Hospital Erasto Gaertner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Drug administration; Other Names: Dexamethasone
Active Comparator: Group 2: corticosteroid; Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days	Drug: Dexamethasone; Drug administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 30 days, the values will be compared to those obtained on the first consultant.
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.	After 30 days, the values will be compared to those obtained on the first consultant.
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	After 30 days, the values will be compared to those obtained on the first consultant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.

Collaborators and Investigators

• Sponsor: Hospital Erasto Gaertner
• Investigators: Principal Investigator: Vinicius B Preti, MD, Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Malnutrition; Cachexia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Bone Density Conservation Agents; Androgens; Anabolic Agents; Dexamethasone; Dexamethasone acetate; BB 1101; Nandrolone; Nandrolone Decanoate; Nandrolone phenpropionate
• Other Study ID Numbers: HEG03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No