Clinical trial NCT03263520: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia; Cancer
Lead sponsor: Hospital Erasto Gaertner
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients
timeFrame: After 30 days, the values will be compared to those obtained on the first consultant.
measure: 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)
timeFrame: After 30 days, the values will be compared to those obtained on the first consultant.
measure: 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
timeFrame: After 30 days, the values will be compared to those obtained on the first consultant.
Secondary outcomes:
measure: Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.
timeFrame: After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
Study officials:
affiliation: Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer
name: Vinicius B Preti, MD
role: PRINCIPAL_INVESTIGATOR
References: