Testosterone for Treating Cachexia in Patients With Advanced or Recurrent Cervical Cancer
Conditions
Cachexia - Cervical Cancer
Conditions: official terms
Cachexia - Uterine Cervical Neoplasms
Conditions: Keywords
stage IIB cervical cancer, stage III cervical cancer, recurrent cervical cancer, cachexia
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Intervention
Name: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone Type: Drug
Name: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate Type: Drug
Overall Status
Recruiting
Summary
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 advanced or recurrent cervical cancer to maintain their body weight and muscle size and strength during treatment.
Detailed Description
OBJECTIVES:

- 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 quality-of-life questionnaires.

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: DISEASE CHARACTERISTICS:

- Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent cervical carcinoma

- Weight loss of ≥ 10% within the past 6 months

- No ovarian tumors (e.g., Sertoli-Leydig cell tumor) or androgen-secreting tumors of the ovary or adrenal gland

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Mini Mental State Examination score > 23

- Not pregnant

- No evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes

- No significant liver, renal, or heart disease

- No diabetes mellitus or other untreated endocrine disease

- No polycystic ovary syndrome and/or hyperthecosis

- No non-classical adrenal hyperplasia

- No Cushing's syndrome

- No glucocorticoid resistance

- No hyperprolactinoma or hypothyroidism

- No lactose intolerance

- No alcohol or drug abuse

- No other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician

PRIOR CONCURRENT THERAPY:

- More than 3 months since prior anabolic steroids

- No concurrent anticoagulant therapy
Location
University of Texas Medical Branch
Galveston, Texas, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Texas Medical Branch - 409-772-1950
Start Date
April 2008
Completion Date
February 2015
Sponsors
The University of Texas Medical Branch, Galveston
Source
The University of Texas Medical Branch, Galveston
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page