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Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00878995
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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 squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.


Condition or disease Intervention/treatment Phase
Cachexia Squamous Cell Carcinoma Drug: Placebo Testosterone Drug: Testosterone Enanthate 100 MG/ML Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
Actual Study Start Date : June 3, 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard of Care Therapy + Placebo Testosterone
Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.
Drug: Placebo Testosterone
Placebo (Saline) Testosterone given IM once per week.

Active Comparator: Standard of Care Therapy + Testosterone
Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks.
Drug: Testosterone Enanthate 100 MG/ML
Testosterone Enanthate 100mg/ml given once per week IM.




Primary Outcome Measures :
  1. Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. [ Time Frame: 7 weeks ]
    Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.


Secondary Outcome Measures :
  1. Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline [ Time Frame: Baseline ]
    Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.

  2. Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. [ Time Frame: 7 weeks ]
    Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.

  3. Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. [ Time Frame: Baseline ]
    Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.

  4. Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks [ Time Frame: 7 weeks ]
    Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.

  5. Body Weight as Measured by Scale at Baseline [ Time Frame: Baseline ]
    Body weight in kilograms as measured by a scale at the baseline visit.

  6. Body Weight as Measured by Scale at 7 Weeks. [ Time Frame: 7 weeks ]
    Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.

  7. Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline [ Time Frame: Baseline ]
    Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.

  8. Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks [ Time Frame: 7 weeks ]
    Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.

  9. Physical Activity Levels as Measured by the ActiGraph Accelerometer [ Time Frame: through study completion,up to 7 weeks ]
    Physical activity is reported as % time sedentary for the entire 7 week study.

  10. Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline [ Time Frame: Baseline ]
    Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  11. Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks [ Time Frame: 7 weeks ]
    Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  12. Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  13. Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks [ Time Frame: 7 weeks ]
    Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  14. Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  15. Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  16. Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  17. Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  18. Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  19. Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  20. Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  21. Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  22. Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  23. Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  24. Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  25. Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  26. Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  27. Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  28. Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  29. Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  30. Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  31. Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  32. Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: Baseline ]
    Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  33. Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  34. Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. [ Time Frame: baseline ]
    Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  35. Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. [ Time Frame: 7 weeks ]
    Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.

  36. Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline [ Time Frame: baseline ]
    Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit

  37. Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks [ Time Frame: 7 weeks ]
    Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.

  38. Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline [ Time Frame: baseline ]
    The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.

  39. Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks [ Time Frame: 7 weeks ]
    The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99

  40. Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline [ Time Frame: Baseline ]

    Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.

    There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.

    The range of the total score is -24 to 96, with the higher the number meaning more fatigue.


  41. Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks [ Time Frame: 7 weeks ]

    Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.

    There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.

    The range of the total score is -24 to 96, with the higher the number meaning more fatigue.


  42. Mood Measured by Profile of Mood States at Baseline [ Time Frame: baseline ]
    Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).

  43. Mood as Measured by Profile of Mood States at 7 Weeks [ Time Frame: 7 weeks ]
    Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).

  44. Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline [ Time Frame: Baseline ]
    Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).

  45. Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks [ Time Frame: 7 weeks ]
    Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).

  46. 1-year Survival [ Time Frame: 1 year post study ]
    Number of participants who survived one year post study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878995


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Investigators
Principal Investigator: Melinda Sheffield-Moore, PhD University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00878995     History of Changes
Other Study ID Numbers: 06-073/10-207
R01CA127971 ( U.S. NIH Grant/Contract )
CDR0000629579
GCRC#724/819
First Posted: April 9, 2009    Key Record Dates
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by The University of Texas Medical Branch, Galveston:
stage IIB cervical cancer
stage III cervical cancer
recurrent cervical cancer
cachexia
advanced head/neck carcinoma
recurrent head/neck carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Cachexia
Wasting Syndrome
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents