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

NCT03263520 | Completed DMC

• 1 other identifier: HEG03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cachexia; Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.

Study Arms (2)

Group 1: nandrolone and corticosteroid

EXPERIMENTAL

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

Group 2: corticosteroid

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Nandrolone Decanoate DRUG

Drug administration

Also known as: Dexamethasone

Group 1: nandrolone and corticosteroid

Dexamethasone DRUG

Drug administration

Group 2: corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Erasto Gaertner: lead

Study Sites (1)

Hospital Erasto Gaertner

Curitiba, Paraná, 81520060, Brazil

Location

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Nandrolone Decanoate; Dexamethasone

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Nandrolone; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Study Officials

• Vinicius B Preti, MD

  Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 28, 2017
• Study Start: February 1, 2016
• Primary Completion: August 30, 2017
• Study Completion: October 31, 2017
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

BR (1)