Try our beta test site

Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00878995
First received: April 8, 2009
Last updated: January 12, 2017
Last verified: January 2017

April 8, 2009
January 12, 2017
April 2008
June 2014   (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) at baseline and 7 weeks. [ Time Frame: Baseline and 7 weeks ]
  • Muscle strength and fatigue tests, including tests of maximal voluntary contraction (isometric and isokinetic leg strength on Biodex) at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • Changes in serum inflammatory biomarkers and muscle inflammatory cytokines as measured by immunoassay at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • Changes in NF-kB expression as measured by western analysis at baseline and 7 weeks [ Time Frame: Baseline and 7 weeks ]
  • 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
  • Muscle strength tests, including tests of maximal voluntary contraction (arm and leg extension and handgrip) at baseline and at 1½ and 3 months
  • 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
  • Changes in serum inflammatory biomarkers and muscle inflammatory cytokines as measured by immunoassay at baseline and at 1½ and 3 months
  • 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
  • Changes in NF-kB expression as measured by western analysis at baseline and at 1½ and 3 months
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 ]
  • 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 ]
  • Quality of Life Measurements. [ Time Frame: Weekly ]
    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 ]
  • 1-year survival [ Time Frame: monthly ]
  • Changes in body weight and fat mass as measured by DEXA at baseline and at 1½ and 3 months
  • Appendicular total and muscle volumes as measured by MRI imaging at baseline and at 3 months
  • 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
  • Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations
  • 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
  • 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
  • Physical activity levels, intensities, and energy expenditure as measured by the ActiGraph accelerometer (worn on the hip or ankle)
  • 1-year survival
Not Provided
Not Provided
 
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cachexia
  • Squamous Cell Carcinoma
  • 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.
 
Completed
29
June 2015
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00878995
06-073/10-207
R01CA127971 ( US NIH Grant/Contract Award Number )
CDR0000629579
GCRC#724/819
No
Not Provided
Not Provided
Not Provided
The University of Texas Medical Branch, Galveston
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas
The University of Texas Medical Branch, Galveston
January 2017

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