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

Hospital Erasto Gaertner

Status: Completed

Conditions: Cachexia; Cancer

Treatments: Drug: Nandrolone Decanoate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03263520

HEG03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group 1: nandrolone and corticosteroid

Experimental group

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.

Treatment:

Drug: Nandrolone Decanoate

Group 2: corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone