Back to results

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

Primary Purpose

Cachexia; Cancer

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Nandrolone Decanoate

Dexamethasone

About this trial

This is an interventional supportive care trial for Cachexia; Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Erasto Gaertner

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: nandrolone and corticosteroid

Group 2: corticosteroid

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

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.

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03263520

First Posted

August 15, 2017

Last Updated

February 25, 2019

Sponsor

Hospital Erasto Gaertner

1. Study Identification

Unique Protocol Identification Number

NCT03263520

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

August 30, 2017 (Actual)

Study Completion Date

October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Erasto Gaertner

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cachexia; Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

InvestigatorOutcomes Assessor

Masking Description

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)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: nandrolone and corticosteroid

Arm Type

Experimental

Arm Description

Arm Title

Group 2: corticosteroid

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nandrolone Decanoate

Other Intervention Name(s)

Dexamethasone

Intervention Description

Drug administration

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Drug administration

Primary Outcome Measure Information:

Title

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

Description

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.

Title

Description

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.

Title

Description

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 Outcome Measure Information:

Title

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

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinicius B Preti, MD

Organizational Affiliation

Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Erasto Gaertner

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

81520060

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs