Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
|ClinicalTrials.gov Identifier: NCT00467844|
Recruitment Status : Completed
First Posted : May 1, 2007
Results First Posted : February 21, 2013
Last Update Posted : July 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cachexia||Drug: GTx-024 Drug: Placebo||Phase 2|
Cancer cachexia is characterized by a hypermetabolic state that leads to catabolism that is responsible for reductions in lean mass.These catabolic changes are accompanied by an increase in total energy expenditure, but a decrease in voluntary energy expenditure that ultimately results clinically in cachexia and its symptoms of lethargy, fatigue, weakness and general malaise (Kotler DP. Cachexia. Ann Intern Med. 2000; 133:622-634).
The prevalence of cachexia increases from 50 percent at presentation to more than 80 percent before death from malignancy. In over 20 percent of cancer patients, cachexia is the cause of death (Bruera E. Anorexia, cachexia and nutrition. Br Med J 1997;315:1219-1222). Cancer cachexia leads to shorter survival, decreased response rates and increased toxicity to chemotherapy, weakness, and an overall decreased quality of life (DeWys et al. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7). The purpose of this study is to assess the efficacy of GTx-024 on total body lean mass. Secondary endpoints include but are not limited to assessment of GTx-024 on muscle function, total body weight and total body fat mass.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
1 mg GTx-024
1 mg GTx 024
3 mg GTx-024
3 mg GTx-024
Placebo Comparator: 3
- The Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Baseline to Four Months ]Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
- To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. [ Time Frame: Four Months ]Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467844
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