Cachexia; CancerNCT03263520
Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer
A study testing Nandrolone Decanoate and Dexamethasone in people with Cachexia; Cancer, run by Hospital Erasto Gaertner at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer
- What is being tested?
- Nandrolone Decanoate and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cachexia; Cancer
- Being tested
- Nandrolone Decanoate, Dexamethasone
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nandrolone DecanoateDrug
Also called Dexamethasone
Drug administration
DexamethasoneDrug
Drug administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nandrolone Decanoate |
| Group 2: corticosteroid | Active comparator | Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
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)
Measured: After 30 days, the laboratory test will be collect again and the values will be compared to those obtained on the first consultant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study startFeb 2016
- Primary completion30 Aug 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Erasto Gaertner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinicius B Preti, MD, Principal investigator, Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263520
- Sponsor's protocol ID
- HEG03
- Status last verified
- Feb 2019
- First submitted
- 15 Aug 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer
- ClinicalTrials.gov ID
- NCT03263520
- Acronym / sponsor ID
- HEG03
- Conditions
- Cachexia; Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Erasto GaertnerUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: nandrolone and corticosteroid | Experimental | Drug: Nandrolone Decanoatethe 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. |
| Group 2: corticosteroid | Active comparator | Drug: DexamethasonePatient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nandrolone DecanoateAlso: DexamethasoneDrug administration | Drug | Group 1: nandrolone and corticosteroid |
| DexamethasoneDrug administration | Drug | Group 2: corticosteroid |
Primary outcome
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients
Time frame: After 30 days, the values will be compared to those obtained on the first consultant.
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)
Time frame: After 30 days, the values will be compared to those obtained on the first consultant.
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
Time frame: After 30 days, the values will be compared to those obtained on the first consultant.
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
1 secondary outcome
Compare data from laboratory tests: complete blood count, albumin, C reactive protein and transferrin with drug intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinicius B Preti, MD principal investigator
Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nandrolone Decanoate and Dexamethasone in people with Cachexia; Cancer, run by Hospital Erasto Gaertner at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the use of nandrolone associated with corticosteroid for the treatment of cancer-induced malnutrition to treatment with corticosteroids alone in cancer patients (time frame: After 30 days, the values will be compared to those obtained on the first consultant.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.