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Testosterone for Treating Cachexia in Patients With Advanced or Recurrent Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00878995
First received: April 8, 2009
Last updated: June 5, 2014
Last verified: June 2014

April 8, 2009
June 5, 2014
April 2008
February 2015   (final data collection date for primary 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. [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Muscle strength and fatigue tests, including tests of maximal voluntary contraction (isometric, isotonic and isokinetic arm and leg strength on Biodex) at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Changes in basal muscle protein synthesis and breakdown as measured by stable isotope metabolic studies at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Changes in serum inflammatory biomarkers and muscle inflammatory cytokines as measured by immunoassay at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Changes in Messenger RNA (mRNA) levels of Atrogin-1, MuRF1, and ubiquitin as measured by quantitative real-time PCR at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Changes in NF-kB expression as measured by western analysis at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Bone composition, regional muscle mass, and bone mineral density (lumbar and hip) as measured by dual energy x-ray absorptiometry (DEXA) at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Muscle strength tests, including tests of maximal voluntary contraction (arm and leg extension and handgrip) at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Changes in basal and absorptive muscle protein synthesis and breakdown as measured by stable isotope metabolic studies at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Changes in serum inflammatory biomarkers and muscle inflammatory cytokines as measured by immunoassay at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Changes in mRNA levels of atrogin-1, MuRF1, and ubiquitin as measured by quantitative real-time PCR at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Changes in NF-kB expression as measured by western analysis at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00878995 on ClinicalTrials.gov Archive Site
  • Changes in body weight and fat mass as measured by DEXA at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Change in the protein expression of anabolic and catabolic markers in the skeletal muscle as measured by western blotting at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Measurements. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    Mood, fatigue, and quality of life as measured by the Medical Outcome Study-Short Form - 36 items (MOS-SF-36), the FACT-G, the Multidimensional Fatigue Symptom Inventory, the Profile of Mood States-Short Form (POMS-SF), the MD Anderson Symptom Inventory (MDASI), and the MD Anderson Brief Fatigue Inventory questionnaires
  • Physical activity levels, intensities, and energy expenditure as measured by the ActiGraph accelerometer (worn on the hip or ankle) [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • 1-year survival [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Changes in body weight and fat mass as measured by DEXA at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Appendicular total and muscle volumes as measured by MRI imaging at baseline and at 3 months [ Designated as safety issue: No ]
  • Change in the protein expression of AR and IGF-I in the skeletal muscle as measured by western blotting at baseline and at 1½ and 3 months [ Designated as safety issue: No ]
  • Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations [ Designated as safety issue: No ]
  • Mood, fatigue, and quality of life as measured by the MOS-SF-36, the FACT-G, the Multidimensional Fatigue Symptom Inventory, the POMS-SF, the MDASI, and the MD Anderson Brief Fatigue Inventory questionnaires [ Designated as safety issue: No ]
  • Adherence to supplement and diet schedules as measured by daily supplement compliance records; fatigue and nausea experienced at the time of meal or supplement consumption as measured by a visual analog scale; and caloric intake [ Designated as safety issue: No ]
  • Physical activity levels, intensities, and energy expenditure as measured by the ActiGraph accelerometer (worn on the hip or ankle) [ Designated as safety issue: No ]
  • 1-year survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Testosterone for Treating Cachexia in Patients With Advanced or Recurrent Cervical Cancer
Nutrition and Anabolic Interventions in Cancer Cachexia

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cachexia
  • Cervical Cancer
  • Drug: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
    Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
  • Drug: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
    Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
  • Placebo Comparator: Arm I: Standard of Care Therapy + Placebo Testosterone
    Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
    Intervention: Drug: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone
  • Active Comparator: Arm II: Standard of Care Therapy + Testosterone
    Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.
    Intervention: Drug: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
United States
 
NCT00878995
06-073, R01CA127971, CDR0000629579, GCRC#724
No
The University of Texas, Galveston
The University of Texas, Galveston
National Cancer Institute (NCI)
Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas
The University of Texas, Galveston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP