Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Other Indications, Women's Studies |
| Therapuetic Areas: | Oncology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | June 3, 2009 |
| End Date: | June 2015 |
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.
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.
- 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.
Inclusion Criteria:
- Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Mini Mental State Examination score > 23
Exclusion Criteria:
- Pregnancy
- Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
- Significant liver, renal, or heart disease
- Diabetes mellitus or other untreated endocrine disease
- Polycystic ovary syndrome and/or hyperthecosis
- Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g.,
Sertoli- Leydig cell tumor)
- Non-classical adrenal hyperplasia
- Cushing's syndrome
- Glucocorticoid resistance
- Hyperprolactinoma or hypothyroidism
- Lactose intolerance
- Alcohol or drug abuse
- Recent treatment (within 3 months) with anabolic steroids
- Ongoing anticoagulant therapy
- Any other circumstance that would preclude study participation, in the opinion of the
principal investigator or study physician
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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