Squamous Cell Carcinoma Clinical Trial
Official title:
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in
patients with cachexia caused by cancer.
PURPOSE: This randomized phase I trial is studying whether testosterone administered during
standard of care chemotherapy and/or radiation works by helping patients with squamous cell
carcinoma to maintain their body weight and muscle size and strength during treatment.
OBJECTIVES:
- To determine the effect of testosterone therapy on lean body mass and muscle strength in
patients with advanced or recurrent squamous cell carcinoma.
- To determine the testosterone therapy on inflammatory biomarkers in patients with
advanced or recurrent squamous cell carcinoma.
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, indirect calorimetry studies, and assessment of their physical activity
level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life
questionnaires.
Blood, muscle tissue, and urine samples are collected periodically for laboratory studies.
Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by
immunoassay.
After completion of study treatment, patients are followed periodically for 1 year.
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