Spots Global Cancer Trial Database for Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
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Trial Identification
Brief Title: Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Official Title: Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
Study ID: NCT00467844
Conditions
Study Description
Brief Summary: The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass in subjects with muscle wasting related to cancer.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Cancer Research and Education Center, Anchorage, Alaska, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Compassionate Cancer Care, Corona, California, United States
Compassionate Cancer Care Medical Group, Fountain Valley, California, United States
Pacific Coast Hematology/Oncology Medical Group, Inc., Fountain Valley, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
Compassionate Cancer Care, Riverside, California, United States
Penrose Cancer Center, Colorado Springs, Colorado, United States
Dorcy Cancer Center, Pueblo, Colorado, United States
Hartford Hospital Cancer Clinical Research Office, Hartford, Connecticut, United States
Medical Oncology & Hematology, PC, Waterbury, Connecticut, United States
Gainesville Hematology Oncology Associates, Gainesville, Florida, United States
Horizon Institute for Clinical Research, Hollywood, Florida, United States
Hematology Oncology Associates, Lake Worth, Florida, United States
The Radiation Oncology Group, Lake Worth, Florida, United States
Watson Clinic LLP, Center for Cancer Care & Research, Lakeland, Florida, United States
Osler Medical, Melbourne, Florida, United States
Innovative Medical Research of South Florida, Inc., Miami, Florida, United States
Florida Medical Clinic, PA, Zephyrhills, Florida, United States
Augusta Oncology Associates, Augusta, Georgia, United States
Dublin Hematology and Oncology, Dublin, Georgia, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Kentuckiana Cancer Institute, Louisville, Kentucky, United States
Johns Hopkins University Clinical Trial Unit, Baltimore, Maryland, United States
Center for Cancer & Blood Disorders, Bethesda, Maryland, United States
The Center for Clinical Research WA County Hospital, Hagerstown, Maryland, United States
Newland Medical Center, Southfield, Michigan, United States
The West Clinic, Corinth, Mississippi, United States
West Clinic, Corinth, Mississippi, United States
The West Clinic, Southaven, Mississippi, United States
West Clinic, Southaven, Mississippi, United States
Hematology & Oncology Associates at Bridgeport, Tupelo, Mississippi, United States
Heartland Hematology-Oncology Associates, Kansas City, Missouri, United States
Donald H. Berdeaux, MD, FACP, PC, Great Falls, Montana, United States
Great Falls Clinic, LLP - Clinic Cancer Care, Great Falls, Montana, United States
Creighton University Hematology/Oncology Clinic, Omaha, Nebraska, United States
Cancer Care of Western North Carolina, Ashville, North Carolina, United States
Four Seasons Hospice & Palliative Care, Flat Rock, North Carolina, United States
Hanover Medical Specialists, Wilmington, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
Signal Point Clinical Research Center, LLC, Middletown, Ohio, United States
Hematology Oncology Consultants, Worthington, Ohio, United States
Consultants in Medical Oncology and Hematology, Drexel Hill, Pennsylvania, United States
Urological Associates of Lancaster, Lancaster, Pennsylvania, United States
Berks Hematology-Oncology Associates, West Reading, Pennsylvania, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
West Clinic, Memphis, Tennessee, United States
West Clinic, Memphis, Tennessee, United States
Dallas Oncology Consultants, Dallas, Texas, United States
Providence Everett Medical Center, Cancer Research Department, Everett, Washington, United States
University of Alberta Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
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