Nutrition and Anabolic Interventions in Cancer Cachexia
18 Years
65 Years
Female
Cachexia, Cervical Cancer
Trial Information
Nutrition and Anabolic Interventions in Cancer Cachexia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
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.
Outcome Time Frame:
Baseline and 7 weeks
Safety Issue:
No
Principal Investigator
Melinda Sheffield-Moore, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Texas
Authority:
United States: Institutional Review Board
Study ID:
06-073
NCT ID:
NCT00878995
Start Date:
April 2008
Completion Date:
March 2015
Related Keywords:
- Cachexia
- Cervical Cancer
- stage IIB cervical cancer
- stage III cervical cancer
- recurrent cervical cancer
- cachexia
- Cachexia
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
