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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group 2: corticosteroid | Active Comparator | Patient will take corticosteroids ( 4 mg of dexamethasone) per oral, QD at morning for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nandrolone Decanoate | Drug | Drug administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinicius B Preti, MD | Hospital Erasto Gaertner/ Liga Paranaense de Combate ao Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Erasto Gaertner | Curitiba | Paraná | 81520060 | Brazil |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077603 | Nandrolone Decanoate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009277 | Nandrolone |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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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.
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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)
| Dexamethasone | Drug | Drug administration |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |