Nutrition and Anabolic Interventions in Cancer Cachexia
- To determine the effect of testosterone therapy on lean body mass and muscle strength
in patients with advanced or recurrent cervical carcinoma and cachexia.
- To determine the effect of testosterone therapy on muscle protein synthesis and
breakdown in patients with advanced or recurrent cervical carcinoma and cachexia.
- To determine the testosterone therapy on inflammatory biomarkers and signaling pathways
involved in the regulation of muscle atrophy in patients with advanced or recurrent
cervical carcinoma and cachexia.
OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo
testosterone intramuscularly (IM) weekly for 7 weeks.
- Arm II: Patients receive standard of care chemotherapy and/or radiation and
testosterone IM weekly for 7 weeks.
Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope
metabolic studies, MRI scan, indirect calorimetry studies, and assessment of their physical
activity level, and nutritional counseling. Patients also complete mood, fatigue, and
Blood, muscle tissue, and saliva samples are collected periodically for laboratory studies.
Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by
immunoassay; (Atrogin-1) a muscle-specific F-box protein highly expressed during muscle
atrophy, Muscle-specific RING-finger protein 1(MuRF1), and ubiquitin expression by
quantitative real-time polymerase chain reaction(PCR); and Nuclear Factor-KappaB (NF-kB)
expression by western analysis.
After completion of study treatment, patients are followed periodically for 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Total lean body mass and regional muscle mass as measured by dual energy x-ray absorptiometry (DEXA) and leg muscle volume as measured by MRI at baseline and 7 weeks.
Baseline and 7 weeks
Melinda Sheffield-Moore, PhD
University of Texas
United States: Institutional Review Board
|University of Texas Medical Branch||Galveston, Texas 77555-1329|