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

Cachexia; Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263520
• Other study ID #: HEG03
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: February 2019
• Source: Hospital Erasto Gaertner
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer
• Malnutrition

Intervention

Drug:
• Nandrolone Decanoate
Drug administration
• Dexamethasone
Drug administration

Locations

Country	Name	City	State
Brazil	Hospital Erasto Gaertner	Curitiba	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Erasto Gaertner

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.